Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biospecimen Collection in Identifying Genetic Changes in Patients With Breast, Prostate, Colorectal, Liver, or Kidney Cancer or Multiple Myeloma Undergoing Surgery

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: NCT04955808
Recruitment Status : Recruiting
First Posted : July 9, 2021
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This research trial studies how well biospecimen collection works in identifying genetic changes in patients with breast, prostate, colorectal, liver, or kidney cancer or multiple myeloma undergoing surgery. Studying samples collected during surgery may add to the understanding of cancer by looking for the genetic changes that cause early cancer onset in people of certain racial and ethnic groups.

Condition or disease Intervention/treatment
Breast Carcinoma Colon Carcinoma Invasive Carcinoma Kidney Carcinoma Liver and Intrahepatic Bile Duct Carcinoma Malignant Solid Neoplasm Plasma Cell Myeloma Prostate Carcinoma Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis

Detailed Description:

PRIMARY OBJECTIVE:

I. To acquire tissue and blood, and other biospecimens for research purposes during procedures for clinical care to accelerate our understanding of the molecular basis of early onset cancers occurring in racial and/or ethnic minority populations through the application of genome analysis technologies, including large- scale genome sequencing and clinical data analysis.

OUTLINE:

Patients undergo collection of tumor tissue during surgery. Patients also undergo blood samples. Samples collected may undergo genetic analysis including whole exome sequencing.

After completion of study, patients are followed for up at 6 and 12 months.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Onset Malignancies Initiative (EOMI): Molecular Profiling of Breast, Colon, Kidney, Liver, Multiple Myeloma, and Prostate Among Racially and Ethnically Diverse Populations
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : December 31, 2023


Group/Cohort Intervention/treatment
Ancillary-correlative (biospecimen collection)
Patients undergo collection of tumor tissue during surgery. Patients also undergo blood samples. Samples collected may undergo genetic analysis including whole exome sequencing.
Procedure: Biospecimen Collection
Undergo collection of tissue and blood samples
Other Name: Biological Sample Collection

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Acquisition of tissue, blood, and other biospecimens for research purposes [ Time Frame: Up to 3 years ]
    Will be performed.


Biospecimen Retention:   Samples With DNA
Tissue, blood


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgery to remove tumor tissue
Criteria

Inclusion Criteria:

  • Patients with either:

    • Histologically confirmed invasive carcinoma or multiple myeloma OR
    • Clinical diagnosis of carcinoma or multiple myeloma OR
    • Suspected clinical diagnosis of multiple myeloma
  • Patients with one of following tumor types and age ranges:

    • Breast cancer diagnosis at ages 18-45
    • Colon cancer diagnosis at ages 18-55
    • Kidney cancer at diagnosis at ages 18-50 (American Indian or Alaska Native [AIAN] and non-Hispanic Whites [NHW] only)
    • Liver cancer diagnosis at ages 18-55
    • Prostate cancer diagnosis at ages 18-55
    • Multiple myeloma diagnosis at ages 18-50
  • Patients whose tumor specimen was collected or will be collected during one of the following routine procedures:

    • Surgery to remove cancer OR
    • Routine biopsy procedures performed to confirm a histologic diagnosis OR
    • Routine biopsy procedure performed to obtain additional tumor material for routine prognostic or predictive biomarkers OR
    • Routine procedure to place a vascular access device prior for systemic therapy
  • Patients who have received no therapy for their cancer other than surgery, irrespective of stage
  • Collection of specimens from living patients:

    • Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol
  • Collection of specimens from deceased patients:

    • Banked tissue samples and/or banked biologic fluid specimens of deceased patients may be used as long as all samples or specimens are properly de- identified prior to submission
  • Sites must use the Central Institutional Review Board for the National Cancer Institute (NCI CIRB).

Exclusion Criteria:

  • Patients who do not meet criteria for an early onset malignancy
  • Prior systemic therapy or radiation therapy for their malignancy
  • Tumor does not meet quality metrics
  • Patient refused consent for use of tissue for research activities included in the Early Onset Malignancies Initiative
  • A diagnosis of a synchronous invasive malignancy
  • Patients with a history of invasive cancer or hematologic malignancy in preceding 5 years

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): NCT04955808


Locations
Layout table for location information
United States, Maryland
National Cancer Institute Division of Cancer Prevention Recruiting
Rockville, Maryland, United States, 20850
Contact: Michelle Bennett       LMBennett@nih.gov   
Principal Investigator: Michelle Bennett         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Michelle Bennett National Cancer Institute Division of Cancer Prevention
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04955808    
Other Study ID Numbers: NCI-2017-01572
NCI-2017-01572 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
DCP-002 ( Other Identifier: National Cancer Institute Division of Cancer Prevention )
DCP-002 ( Other Identifier: DCP )
DCP-002 ( Other Identifier: CTEP )
First Posted: July 9, 2021    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Plasma Cell
Breast Neoplasms
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Multiple Myeloma
Carcinoma, Renal Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Breast Diseases
Skin Diseases
Adenocarcinoma
Kidney Diseases
Urologic Diseases