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Exercise Exposure Data Collection in Patients Undergoing Tumor Molecular Profiling

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208374
Recruitment Status : Active, not recruiting
First Posted : July 5, 2017
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

This study will recruit approximately 5,000 patients with histologically confirmed cancer who have successfully completed MSK-IMPACT panel testing and collect information about tumor genetic results and patient exercise behavior history.

The purpose of the study is to create a registry to collect exercise behavior history in patients who had IMPACT genetic panel testing on protocol IRB #12-245 "Genomic Profiling in Cancer Patients", IRB #06-107 "Storage and Research Use of Human Biospecimens," or IRB #09-141 "Collection of Human Biological Specimens from Patients for Research Studies." The investigators want to find a way to create an exercise database. This database will collect information about tumor genetic results and patient exercise behavior history.


Condition or disease Intervention/treatment
Cancer Carcinoma Behavioral: Prior Exercise Behavior Questions - Harvard Health Professionals Exercise Questionnaire Behavioral: Current Exercise Behavior Questions: International Physical Activity Questionnaire Short Form (IPAQ SF)

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Study Type : Observational
Actual Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exercise Exposure Data Collection in Patients Undergoing Tumor Molecular Profiling
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MSK-IMPACT genetic panel testing
Participants have completed MSK-IMPACT genetic panel testing on Memorial Sloan Kettering Cancer Center protocol IRB #12-245 and/or IRB #06-107 and/or IRB # 09-141 in the last 3 years.
Behavioral: Prior Exercise Behavior Questions - Harvard Health Professionals Exercise Questionnaire
Participants will be asked how often on average over the year prior to their most recent diagnosis they participated in walking or hiking; jogging; running; calisthenics, aerobics, rowing, Nordic track; bicycling; tennis, squash, racquetball; lap swimming; weightlifting; and other aerobic exercise (e.g. heavy outdoor work), as well as their usual walking pace and flights of stairs climbed daily over the past 12 months prior to diagnosis.

Behavioral: Current Exercise Behavior Questions: International Physical Activity Questionnaire Short Form (IPAQ SF)
The purpose of this questionnaire is to provide common instruments that can be used to obtain internationally comparable data on exercise exposure in adults aged 15 to 80 years old.
Other Name: IPAQ SF




Primary Outcome Measures :
  1. Characterize exercise participant behavior history via exercise survey [ Time Frame: Up to 5 years ]
    Participants who have undergone MSK-IMPACT panel testing will complete the exercise history survey. The 10 minute survey only asks participants about their exercise history, both in period before their most recent diagnosis as well as their current exercise behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study cohort will consist of approximately 5,000 participants with histology confirmed cancer who have successfully completed MSK-IMPACT panel testing and are being treated at any Memorial Sloan Kettering Cancer Center site.
Criteria

Cohort 1: IMPACT Cohort

Inclusion Criteria:

  • Histologically-confirmed cancer.
  • IMPACT testing with completed genomic profile completed within three years of initial recruitment approach
  • Registered to Memorial Sloan Kettering Cancer Center protocol IRB# 12-245 and/or IRB #06-107 and/or IRB # 09-141
  • ≥ 18 years of age
  • ECOG Performance Status of 0 or 1

Exclusion Criteria:

  • Unable to speak and read English
  • Not willing to provide informed consent

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): NCT03208374


Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
Memoral Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Lee Jones, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03208374    
Other Study ID Numbers: 17-327
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Memorial Sloan Kettering Cancer Center:
Histologically confirmed cancer
IMPACT testing
17-327