Preserving Fertility After Colorectal Cancer Study

NCT05239338 | Recruiting

• 1 other identifier: VICC GI 2186
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (7)

• Change(s) in serum hormonal markers

  For female patients not taking oral contraceptive pills (OCPs), serum hormonal markers to be measured include: anti-Mullerian hormone (AMH), estrogens, sex hormone binding globulin (SHBG), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and androgens. For male patients, serum hormonal markers to be measured include: inhibin B, FSH, androgens, estrogens, SHBG and LH.

  Baseline, treatment and multiple surveillance timepoints (up to 5 years)

• Reproductive health history (Questionnaire)

  Baseline timepoint

• Change(s) in reproductive health (Questionnaire)

  Baseline, treatment and multiple surveillance timepoints (up to 5 years)

• Sexual health history (Questionnaire)

  Baseline timepoint

• Changes in sexual health (Questionnaire)

  Baseline, treatment and multiple surveillance timepoints (Up to 5 years)

• Sexual health (Interview)

  9 month post-treatment/Surveillance timepoint

• Disease-free survival

  Up to 5 years

Secondary Outcomes (6)

• Change(s) in health-related quality of life (Questionnaire)

  At baseline, treatment and multiple surveillance timepoints (Up to 5 years)

• Physical activity (Accelerometer)

  Baseline timepoint

• Physical activity (Accelerometer)

  Completion of first-course treatment (or 9 months after baseline)

• Physical activity (Accelerometer)

  9 month post-treatment/Surveillance timepoint

• Physical activity (Accelerometer)

  18 month post-treatment/Surveillance timepoint

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with colorectal cancer between the ages of 18 to 49 years.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andreana Holowatyj, PhD, MSCI: lead

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• PREFACE Study Website

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Andreana N Holowatyj, PhD, MSCI

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PREFACE Study Coordinator (Rebecca B.)

CONTACT

615-936-6204; prefacestudy@vumc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: February 14, 2022
• Study Start: December 6, 2021
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): December 1, 2037
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

US (1)