Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2021-12-06
2037-12-31
Brief Summary
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Detailed Description
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Patients are recruited prior to colorectal cancer therapy \[baseline\] and followed for up to 36 months after completion of first-course therapy (or 45 months after diagnosis for patients on maintenance therapy). Study timepoints are defined at: (i) completion of first-course treatment (or 9 months after diagnosis for patients on maintenance therapy \[treatment\]); (ii) and at 9, 18 and 36 month intervals thereafter \[surveillance\]. This cohort is enriched by a robust collection of biospecimens and data.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PREFACE: Vanderbilt-Ingram Cancer Center
Patient recruitment and follow-up, longitudinal collection of data and multiple biospecimen at pre-defined study timepoints, objective assessment of health behaviors/habits, individual interviews.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 49 years at colorectal cancer diagnosis
* Diagnosed by and/or consulting with a physician participating in the PREFACE Study
* No prior history of colorectal cancer and/or colorectal cancer treatment
* Mentally and physically able to consent and participate in the study
Exclusion Criteria
* Prisoners
* Unable to provide informed consent
* Unable to read, write, or complete questionnaires in English
18 Years
49 Years
ALL
No
Sponsors
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Andreana Holowatyj, PhD, MSCI
OTHER
Responsible Party
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Andreana Holowatyj, PhD, MSCI
Sponsor Investigator
Principal Investigators
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Andreana N Holowatyj, PhD, MSCI
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Holowatyj AN, Eng C, Lewis MA. Incorporating Reproductive Health in the Clinical Management of Early-Onset Colorectal Cancer. JCO Oncol Pract. 2022 Mar;18(3):169-172. doi: 10.1200/OP.21.00525. Epub 2021 Sep 23. No abstract available.
Eng C, Jacome AA, Agarwal R, Hayat MH, Byndloss MX, Holowatyj AN, Bailey C, Lieu CH. A comprehensive framework for early-onset colorectal cancer research. Lancet Oncol. 2022 Mar;23(3):e116-e128. doi: 10.1016/S1470-2045(21)00588-X. Epub 2022 Jan 31.
Keller SR, Rosen A, Lewis MA, Park HK, Babyak R, Feldman J, Ye F, Agarwal R, Ciombor KK, Geiger TM, Eng C, Hunzinger KJ, Viskochil RH, Roach MK, Velez Edwards DR, Cote ML, Holowatyj AN. Patient-Reported Discussions on Fertility Preservation Before Early-Onset Cancer Treatment. JAMA Netw Open. 2024 Nov 4;7(11):e2444540. doi: 10.1001/jamanetworkopen.2024.44540.
Related Links
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PREFACE Study Website
Other Identifiers
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VICC GI 2186
Identifier Type: -
Identifier Source: org_study_id
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