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ColoCare Study - Colorectal Cancer Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328677
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
German Cancer Research Center
H. Lee Moffitt Cancer Center and Research Institute
Huntsman Cancer Institute
Cedars-Sinai Medical Center
Washington University School of Medicine
University of Tennessee
Information provided by (Responsible Party):
Cornelia Ulrich, University of Utah

Brief Summary:
ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20).

Condition or disease
Colorectal Cancer

Detailed Description:

The ColoCare Consortium is a multicenter initiative establishing an international cohort of colorectal cancer (CRC) patients for interdisciplinary studies of CRC prognosis and outcomes with sites at the Fred Hutchinson Cancer Research Center, Seattle (Washington, USA), H. Lee Moffitt Cancer Center and Research Institute, Tampa (Florida, USA), the University Hospital Heidelberg (Germany), the Huntsman Cancer Institute (Utah, USA), the Cedars-Senai Medical Center (California, USA), University of Washington St. Louis (Missouri, USA), and University of Tennessee (Tennessee, USA). Additional information is provided in the study design paper, that has been published in 2019 (https://pubmed.ncbi.nlm.nih.gov/30523039/).

Aims: The ColoCare Study investigates clinical outcomes, including disease-free and overall survival, predictors of cancer recurrence, survival, health-related quality-of-life and treatment toxicities. In addition, cross-sectional analyses of biomarkers and/or health behaviors are undertaken.

Patients are recruited at baseline (time of first diagnosis) and followed for up to 5 years at regular timepoints (3m, 6m, 12m, 24m, 36m, 48m, 60m). The cohort includes a comprehensive collection of specimens and data.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ColoCare Transdisciplinary Research in Colorectal Cancer Prognosis
Study Start Date : March 2007
Estimated Primary Completion Date : October 2030
Estimated Study Completion Date : October 2030

Resource links provided by the National Library of Medicine


Group/Cohort
ColoCare FHCRC
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status April 30, 2020: n=611
ColoCare Moffitt (affiliated cohort)
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status April 30, 2020: n=835
University Hospital Heidelberg
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status April 30, 2020: n=683
ColoCare Huntsman Cancer Institute
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status April 30, 2020: n=294
Cedars-Sinai Medical Center
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status April 30, 2020: n=203
University of Washington St. Louis
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status April 30, 2020: n=195
University of Tennessee
Active patient recruitment, follow-up, and multiple specimen collection Repeated sampling at multiple timepoints Longitudinal assessment of biomarkers and health behaviors Recruitment Status April 30, 2020: n=153



Primary Outcome Measures :
  1. Disease-free and overall survival [ Time Frame: up to 10 years ]
  2. Recurrence [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: at 0, 3, 6, 12, 24, 36, 48, 60 months post recruitment ]
  2. Treatment toxicities [ Time Frame: up to 5 years post treatment ]

Biospecimen Retention:   Samples With DNA
blood, urine, feces, saliva, FFPE and fresh frozen tissue (multiple sources/locations) from the tumor, DNA, RNA, miRNA, visceral adipose tissue and subcutaneous adipose tissue.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ColoCare is an international prospective cohort study of stage I-IV colorectal cancer patients (ICD-10 C18-C20). The ColoCare Consortium is a multicenter initiative of interdisciplinary research on CRC outcome and prognosis, and comprises patient recruitment at 6 sites. Patients are recruited at baseline (time of first diagnosis, time prior to surgery or during treatment (FHCRC and HCI)) and followed for up to 10 years at regular timepoints (3m, 6m, 12m, 24m, 36m, 48m, 60m). The cohort includes a comprehensive collection of biospecimens and data.
Criteria

Inclusion Criteria:

  1. Age 18-89 years;
  2. Men and Women
  3. Newly-diagnosed colon or rectal cancer (stages I-IV); CRC in treatment (FHCRC and HCI)
  4. English (FHCRC, Moffitt, HCI, Cedars-Senai, UW St. Louis, UT) or German (University Hospital Heidelberg)-speaking;
  5. mentally/physically able to consent and participate.

Exclusion Criteria:

  • if one of the above in not fulfilled
  • insufficient language or consent capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328677


Contacts
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Contact: Cornelia Ulrich, MS, PhD (801) 213-5716 neli.ulrich@hci.utah.edu
Contact: Erin Siegel, MD 813-745-6533 erin.siegel@moffitt.org

Locations
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United States, California
Cedars-Senai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Jane Figueiredo, PhD       janefigu@usc.edu   
United States, Florida
Lee H. Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 12902
Contact: Erin Siegel, PhD       Erin.siegel@moffitt.org   
United States, Missouri
University of Washington Recruiting
Saint Louis, Missouri, United States, 63112
Contact: Adetunji T Toriola, MD, PhD       a.toriola@wustl.edu   
United States, Tennessee
University of Tennessee Recruiting
Knoxville, Tennessee, United States, 37996
Contact: David Shibata, MD       dshibata@uthsc.edu   
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Cornelia Ulrich, MS, PhD       neli.ulrich@hci.utah.edu   
United States, Washington
FHCRC Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Christopher Li, MD, PhD       cili@fhcrc.org   
Contact: William Grady, MD, PhD       wgrady@fhcrc.org   
Germany
University Hospital Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Martin Schneider, MD       Martin.Schneider@med.uni-heidelberg.de   
Sponsors and Collaborators
University of Utah
German Cancer Research Center
H. Lee Moffitt Cancer Center and Research Institute
Huntsman Cancer Institute
Cedars-Sinai Medical Center
Washington University School of Medicine
University of Tennessee
Investigators
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Principal Investigator: Cornelia M Ulrich, MS, PhD Huntsman Cancer Institute
Principal Investigator: William Grady, MD, PhD Fred Hutchinson Cancer Research Center
Principal Investigator: Martin Schneider, MD University Hospital Heidelberg
Principal Investigator: Christopher Li, MD Fred Hutchinson Cancer Research Center
Principal Investigator: Erin Siegel, PhD Lee H. Moffitt Cancer Center
Principal Investigator: Jane Figueireido, PhD Cedars-Senai Medical Center
Principal Investigator: David Shibata, MD University of Tennesee
Principal Investigator: Adetunji T. Toriola, MD, PhD University of Washington St. Louis
Publications of Results:
Garcia-Albeniz X, Rudolph A, Hutter C, White E, Lin Y, Rosse SA, Figueiredo JC, Harrison TA, Jiao S, Brenner H, Casey G, Hudson TJ, Thornquist M, Le Marchand L, Potter J, Slattery ML, Zanke B, Baron JA, Caan BJ, Chanock SJ, Berndt SI, Stelling D, Fuchs CS, Hoffmeister M, Butterbach K, Du M, James Gauderman W, Gunter MJ, Lemire M, Ogino S, Lin J, Hayes RB, Haile RW, Schoen RE, Warnick GS, Jenkins MA, Thibodeau SN, Schumacher FR, Lindor NM, Kolonel LN, Hopper JL, Gong J, Seminara D, Pflugeisen BM, Ulrich CM, Qu C, Duggan D, Cotterchio M, Campbell PT, Carlson CS, Newcomb PA, Giovannucci E, Hsu L, Chan AT, Peters U, Chang-Claude J. CYP24A1 variant modifies the association between use of oestrogen plus progestogen therapy and colorectal cancer risk. Br J Cancer. 2016 Jan 19;114(2):221-9. doi: 10.1038/bjc.2015.443. Epub 2016 Jan 14.
Schmit SL, Edlund CK, Schumacher FR, Gong J, Harrison TA, Huyghe JR, Qu C, Melas M, Van Den Berg DJ, Wang H, Tring S, Plummer SJ, Albanes D, Alonso MH, Amos CI, Anton K, Aragaki AK, Arndt V, Barry EL, Berndt SI, Bezieau S, Bien S, Bloomer A, Boehm J, Boutron-Ruault MC, Brenner H, Brezina S, Buchanan DD, Butterbach K, Caan BJ, Campbell PT, Carlson CS, Castelao JE, Chan AT, Chang-Claude J, Chanock SJ, Cheng I, Cheng YW, Chin LS, Church JM, Church T, Coetzee GA, Cotterchio M, Cruz Correa M, Curtis KR, Duggan D, Easton DF, English D, Feskens EJM, Fischer R, FitzGerald LM, Fortini BK, Fritsche LG, Fuchs CS, Gago-Dominguez M, Gala M, Gallinger SJ, Gauderman WJ, Giles GG, Giovannucci EL, Gogarten SM, Gonzalez-Villalpando C, Gonzalez-Villalpando EM, Grady WM, Greenson JK, Gsur A, Gunter M, Haiman CA, Hampe J, Harlid S, Harju JF, Hayes RB, Hofer P, Hoffmeister M, Hopper JL, Huang SC, Huerta JM, Hudson TJ, Hunter DJ, Idos GE, Iwasaki M, Jackson RD, Jacobs EJ, Jee SH, Jenkins MA, Jia WH, Jiao S, Joshi AD, Kolonel LN, Kono S, Kooperberg C, Krogh V, Kuehn T, Küry S, LaCroix A, Laurie CA, Lejbkowicz F, Lemire M, Lenz HJ, Levine D, Li CI, Li L, Lieb W, Lin Y, Lindor NM, Liu YR, Loupakis F, Lu Y, Luh F, Ma J, Mancao C, Manion FJ, Markowitz SD, Martin V, Matsuda K, Matsuo K, McDonnell KJ, McNeil CE, Milne R, Molina AJ, Mukherjee B, Murphy N, Newcomb PA, Offit K, Omichessan H, Palli D, Cotoré JPP, Pérez-Mayoral J, Pharoah PD, Potter JD, Qu C, Raskin L, Rennert G, Rennert HS, Riggs BM, Schafmayer C, Schoen RE, Sellers TA, Seminara D, Severi G, Shi W, Shibata D, Shu XO, Siegel EM, Slattery ML, Southey M, Stadler ZK, Stern MC, Stintzing S, Taverna D, Thibodeau SN, Thomas DC, Trichopoulou A, Tsugane S, Ulrich CM, van Duijnhoven FJB, van Guelpan B, Vijai J, Virtamo J, Weinstein SJ, White E, Win AK, Wolk A, Woods M, Wu AH, Wu K, Xiang YB, Yen Y, Zanke BW, Zeng YX, Zhang B, Zubair N, Kweon SS, Figueiredo JC, Zheng W, Marchand LL, Lindblom A, Moreno V, Peters U, Casey G, Hsu L, Conti DV, Gruber SB. Novel Common Genetic Susceptibility Loci for Colorectal Cancer. J Natl Cancer Inst. 2019 Feb 1;111(2):146-157. doi: 10.1093/jnci/djy099.
Huyghe JR, Bien SA, Harrison TA, Kang HM, Chen S, Schmit SL, Conti DV, Qu C, Jeon J, Edlund CK, Greenside P, Wainberg M, Schumacher FR, Smith JD, Levine DM, Nelson SC, Sinnott-Armstrong NA, Albanes D, Alonso MH, Anderson K, Arnau-Collell C, Arndt V, Bamia C, Banbury BL, Baron JA, Berndt SI, Bézieau S, Bishop DT, Boehm J, Boeing H, Brenner H, Brezina S, Buch S, Buchanan DD, Burnett-Hartman A, Butterbach K, Caan BJ, Campbell PT, Carlson CS, Castellví-Bel S, Chan AT, Chang-Claude J, Chanock SJ, Chirlaque MD, Cho SH, Connolly CM, Cross AJ, Cuk K, Curtis KR, de la Chapelle A, Doheny KF, Duggan D, Easton DF, Elias SG, Elliott F, English DR, Feskens EJM, Figueiredo JC, Fischer R, FitzGerald LM, Forman D, Gala M, Gallinger S, Gauderman WJ, Giles GG, Gillanders E, Gong J, Goodman PJ, Grady WM, Grove JS, Gsur A, Gunter MJ, Haile RW, Hampe J, Hampel H, Harlid S, Hayes RB, Hofer P, Hoffmeister M, Hopper JL, Hsu WL, Huang WY, Hudson TJ, Hunter DJ, Ibañez-Sanz G, Idos GE, Ingersoll R, Jackson RD, Jacobs EJ, Jenkins MA, Joshi AD, Joshu CE, Keku TO, Key TJ, Kim HR, Kobayashi E, Kolonel LN, Kooperberg C, Kühn T, Küry S, Kweon SS, Larsson SC, Laurie CA, Le Marchand L, Leal SM, Lee SC, Lejbkowicz F, Lemire M, Li CI, Li L, Lieb W, Lin Y, Lindblom A, Lindor NM, Ling H, Louie TL, Männistö S, Markowitz SD, Martín V, Masala G, McNeil CE, Melas M, Milne RL, Moreno L, Murphy N, Myte R, Naccarati A, Newcomb PA, Offit K, Ogino S, Onland-Moret NC, Pardini B, Parfrey PS, Pearlman R, Perduca V, Pharoah PDP, Pinchev M, Platz EA, Prentice RL, Pugh E, Raskin L, Rennert G, Rennert HS, Riboli E, Rodríguez-Barranco M, Romm J, Sakoda LC, Schafmayer C, Schoen RE, Seminara D, Shah M, Shelford T, Shin MH, Shulman K, Sieri S, Slattery ML, Southey MC, Stadler ZK, Stegmaier C, Su YR, Tangen CM, Thibodeau SN, Thomas DC, Thomas SS, Toland AE, Trichopoulou A, Ulrich CM, Van Den Berg DJ, van Duijnhoven FJB, Van Guelpen B, van Kranen H, Vijai J, Visvanathan K, Vodicka P, Vodickova L, Vymetalkova V, Weigl K, Weinstein SJ, White E, Win AK, Wolf CR, Wolk A, Woods MO, Wu AH, Zaidi SH, Zanke BW, Zhang Q, Zheng W, Scacheri PC, Potter JD, Bassik MC, Kundaje A, Casey G, Moreno V, Abecasis GR, Nickerson DA, Gruber SB, Hsu L, Peters U. Discovery of common and rare genetic risk variants for colorectal cancer. Nat Genet. 2019 Jan;51(1):76-87. doi: 10.1038/s41588-018-0286-6. Epub 2018 Dec 3.
Bien SA, Su YR, Conti DV, Harrison TA, Qu C, Guo X, Lu Y, Albanes D, Auer PL, Banbury BL, Berndt SI, Bézieau S, Brenner H, Buchanan DD, Caan BJ, Campbell PT, Carlson CS, Chan AT, Chang-Claude J, Chen S, Connolly CM, Easton DF, Feskens EJM, Gallinger S, Giles GG, Gunter MJ, Hampe J, Huyghe JR, Hoffmeister M, Hudson TJ, Jacobs EJ, Jenkins MA, Kampman E, Kang HM, Kühn T, Küry S, Lejbkowicz F, Le Marchand L, Milne RL, Li L, Li CI, Lindblom A, Lindor NM, Martín V, McNeil CE, Melas M, Moreno V, Newcomb PA, Offit K, Pharaoh PDP, Potter JD, Qu C, Riboli E, Rennert G, Sala N, Schafmayer C, Scacheri PC, Schmit SL, Severi G, Slattery ML, Smith JD, Trichopoulou A, Tumino R, Ulrich CM, van Duijnhoven FJB, Van Guelpen B, Weinstein SJ, White E, Wolk A, Woods MO, Wu AH, Abecasis GR, Casey G, Nickerson DA, Gruber SB, Hsu L, Zheng W, Peters U. Genetic variant predictors of gene expression provide new insight into risk of colorectal cancer. Hum Genet. 2019 Apr;138(4):307-326. doi: 10.1007/s00439-019-01989-8. Epub 2019 Feb 28. Erratum in: Hum Genet. 2019 Jun 28;:.
Archambault AN, Su YR, Jeon J, Thomas M, Lin Y, Conti DV, Win AK, Sakoda LC, Lansdorp-Vogelaar I, Peterse EFP, Zauber AG, Duggan D, Holowatyj AN, Huyghe JR, Brenner H, Cotterchio M, Bézieau S, Schmit SL, Edlund CK, Southey MC, MacInnis RJ, Campbell PT, Chang-Claude J, Slattery ML, Chan AT, Joshi AD, Song M, Cao Y, Woods MO, White E, Weinstein SJ, Ulrich CM, Hoffmeister M, Bien SA, Harrison TA, Hampe J, Li CI, Schafmayer C, Offit K, Pharoah PD, Moreno V, Lindblom A, Wolk A, Wu AH, Li L, Gunter MJ, Gsur A, Keku TO, Pearlman R, Bishop DT, Castellví-Bel S, Moreira L, Vodicka P, Kampman E, Giles GG, Albanes D, Baron JA, Berndt SI, Brezina S, Buch S, Buchanan DD, Trichopoulou A, Severi G, Chirlaque MD, Sánchez MJ, Palli D, Kühn T, Murphy N, Cross AJ, Burnett-Hartman AN, Chanock SJ, de la Chapelle A, Easton DF, Elliott F, English DR, Feskens EJM, FitzGerald LM, Goodman PJ, Hopper JL, Hudson TJ, Hunter DJ, Jacobs EJ, Joshu CE, Küry S, Markowitz SD, Milne RL, Platz EA, Rennert G, Rennert HS, Schumacher FR, Sandler RS, Seminara D, Tangen CM, Thibodeau SN, Toland AE, van Duijnhoven FJB, Visvanathan K, Vodickova L, Potter JD, Männistö S, Weigl K, Figueiredo J, Martín V, Larsson SC, Parfrey PS, Huang WY, Lenz HJ, Castelao JE, Gago-Dominguez M, Muñoz-Garzón V, Mancao C, Haiman CA, Wilkens LR, Siegel E, Barry E, Younghusband B, Van Guelpen B, Harlid S, Zeleniuch-Jacquotte A, Liang PS, Du M, Casey G, Lindor NM, Le Marchand L, Gallinger SJ, Jenkins MA, Newcomb PA, Gruber SB, Schoen RE, Hampel H, Corley DA, Hsu L, Peters U, Hayes RB. Cumulative Burden of Colorectal Cancer-Associated Genetic Variants Is More Strongly Associated With Early-Onset vs Late-Onset Cancer. Gastroenterology. 2020 Apr;158(5):1274-1286.e12. doi: 10.1053/j.gastro.2019.12.012. Epub 2019 Dec 19.
Papadimitriou N, Dimou N, Tsilidis KK, Banbury B, Martin RM, Lewis SJ, Kazmi N, Robinson TM, Albanes D, Aleksandrova K, Berndt SI, Timothy Bishop D, Brenner H, Buchanan DD, Bueno-de-Mesquita B, Campbell PT, Castellví-Bel S, Chan AT, Chang-Claude J, Ellingjord-Dale M, Figueiredo JC, Gallinger SJ, Giles GG, Giovannucci E, Gruber SB, Gsur A, Hampe J, Hampel H, Harlid S, Harrison TA, Hoffmeister M, Hopper JL, Hsu L, María Huerta J, Huyghe JR, Jenkins MA, Keku TO, Kühn T, La Vecchia C, Le Marchand L, Li CI, Li L, Lindblom A, Lindor NM, Lynch B, Markowitz SD, Masala G, May AM, Milne R, Monninkhof E, Moreno L, Moreno V, Newcomb PA, Offit K, Perduca V, Pharoah PDP, Platz EA, Potter JD, Rennert G, Riboli E, Sánchez MJ, Schmit SL, Schoen RE, Severi G, Sieri S, Slattery ML, Song M, Tangen CM, Thibodeau SN, Travis RC, Trichopoulou A, Ulrich CM, van Duijnhoven FJB, Van Guelpen B, Vodicka P, White E, Wolk A, Woods MO, Wu AH, Peters U, Gunter MJ, Murphy N. Physical activity and risks of breast and colorectal cancer: a Mendelian randomisation analysis. Nat Commun. 2020 Jan 30;11(1):597. doi: 10.1038/s41467-020-14389-8.

Other Publications:
Yu B, Zanetti KA, Temprosa M, Albanes D, Appel N, Barrera CB, Ben-Shlomo Y, Boerwinkle E, Casas JP, Clish C, Dale C, Dehghan A, Derkach A, Eliassen AH, Elliott P, Fahy E, Gieger C, Gunter MJ, Harada S, Harris T, Herr DR, Herrington D, Hirschhorn JN, Hoover E, Hsing AW, Johansson M, Kelly RS, Khoo CM, Kivimäki M, Kristal BS, Langenberg C, Lasky-Su J, Lawlor DA, Lotta LA, Mangino M, Le Marchand L, Mathé E, Matthews CE, Menni C, Mucci LA, Murphy R, Oresic M, Orwoll E, Ose J, Pereira AC, Playdon MC, Poston L, Price J, Qi Q, Rexrode K, Risch A, Sampson J, Seow WJ, Sesso HD, Shah SH, Shu XO, Smith GCS, Sovio U, Stevens VL, Stolzenberg-Solomon R, Takebayashi T, Tillin T, Travis R, Tzoulaki I, Ulrich CM, Vasan RS, Verma M, Wang Y, Wareham NJ, Wong A, Younes N, Zhao H, Zheng W, Moore SC. The Consortium of Metabolomics Studies (COMETS): Metabolomics in 47 Prospective Cohort Studies. Am J Epidemiol. 2019 Jun 1;188(6):991-1012. doi: 10.1093/aje/kwz028.

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Responsible Party: Cornelia Ulrich, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT02328677    
Obsolete Identifiers: NCT02391597
Other Study ID Numbers: 6407
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cornelia Ulrich, University of Utah:
Colorectal cancer
rectosigmoid
rectum
colon
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases