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Recruiting NCT05239338

Preserving Fertility After Colorectal Cancer Study

— Observational Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Preserving Fertility After Colorectal Cancer: The PREFACE Study

Overview

The PREFACE Study is a prospective, longitudinal cohort study of reproductive health and clinical outcomes among individuals diagnosed with colorectal cancer between age 18 to 49 years.

Detailed description

The Preserving Fertility After Colorectal Cancer (PREFACE) Study comprehensively investigates fertility, sexual health and clinical outcomes along the cancer care continuum among individuals diagnosed with colorectal cancer between age 18 to 49 years.

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.

Primary outcome measures

  • Change(s) in serum hormonal markers [Time frame: Baseline, treatment and multiple surveillance timepoints (up to 5 years)]
  • Reproductive health history (Questionnaire) [Time frame: Baseline timepoint]
  • Change(s) in reproductive health (Questionnaire) [Time frame: Baseline, treatment and multiple surveillance timepoints (up to 5 years)]
  • Sexual health history (Questionnaire) [Time frame: Baseline timepoint]
  • Changes in sexual health (Questionnaire) [Time frame: Baseline, treatment and multiple surveillance timepoints (Up to 5 years)]
  • Sexual health (Interview) [Time frame: 9 month post-treatment/Surveillance timepoint]
  • Disease-free survival [Time frame: Up to 5 years]
Secondary outcome measures (6)
  • Change(s) in health-related quality of life (Questionnaire) [Time frame: At baseline, treatment and multiple surveillance timepoints (Up to 5 years)]
  • Physical activity (Accelerometer) [Time frame: Baseline timepoint]
  • Physical activity (Accelerometer) [Time frame: Completion of first-course treatment (or 9 months after baseline)]
  • Physical activity (Accelerometer) [Time frame: 9 month post-treatment/Surveillance timepoint]
  • Physical activity (Accelerometer) [Time frame: 18 month post-treatment/Surveillance timepoint]
  • Physical activity (Accelerometer) [Time frame: 36 month post-treatment/Surveillance timepoint]

Eligibility criteria

Inclusion criteria

  • Known diagnosis of colorectal cancer
  • 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

  • Women who are pregnant at the time of colorectal cancer diagnosis
  • Prisoners
  • Unable to provide informed consent
  • Unable to read, write, or complete questionnaires in English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Vanderbilt-Ingram Cancer Center — Nashville

Publications

  • 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. PMID 34554830
  • 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. PMID 35090673
  • 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. PMID 39531236

Identifiers

NCT: NCT05239338 · VICC GI 2186

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗