Clinical trial NCT03208374: Exercise Exposure Data Collection in Patients Undergoing Tumor Molecular Profiling
Official title: Exercise Exposure Data Collection in Patients Undergoing Tumor Molecular Profiling
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Carcinoma
Keywords: Histologically confirmed cancer
IMPACT testing
17-327
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Characterize exercise participant behavior history via exercise survey
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lee Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: