Preserving Fertility After Colorectal Cancer Study

Colorectal Cancer Clinical Trial

— PREFACE  

Official title:

Preserving Fertility After Colorectal Cancer: The PREFACE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05239338
• Other study ID #: VICC GI 2186
• Status: Recruiting
• Start date: December 6, 2021
• Est. completion date: December 2037

Study information

• Verified date: April 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: PREFACE Study Coordinator (Rebecca B.)
• Phone: 615-936-6204
• Email: prefacestudy[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2037
• Est. primary completion date: December 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Andreana Holowatyj, PhD, MSCI

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Reproductive health history (Questionnaire)		Baseline timepoint
Primary	Change(s) in reproductive health (Questionnaire)		Baseline, treatment and multiple surveillance timepoints (up to 5 years)
Primary	Sexual health history (Questionnaire)		Baseline timepoint
Primary	Changes in sexual health (Questionnaire)		Baseline, treatment and multiple surveillance timepoints (Up to 5 years)
Primary	Sexual health (Interview)		9 month post-treatment/Surveillance timepoint
Primary	Disease-free survival		Up to 5 years
Secondary	Change(s) in health-related quality of life (Questionnaire)		At baseline, treatment and multiple surveillance timepoints (Up to 5 years)
Secondary	Physical activity (Accelerometer)		Baseline timepoint
Secondary	Physical activity (Accelerometer)		Completion of first-course treatment (or 9 months after baseline)
Secondary	Physical activity (Accelerometer)		9 month post-treatment/Surveillance timepoint
Secondary	Physical activity (Accelerometer)		18 month post-treatment/Surveillance timepoint
Secondary	Physical activity (Accelerometer)		36 month post-treatment/Surveillance timepoint

External Links

•   PREFACE Study Website