NCT04812912

Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer

The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out how cancer treatments (chemotherapy and/or radiation therapy) affect reproductive and sexual health in people with early onset colorectal cancer. The study researchers will observe and track changes in hormone levels and in sexual and reproductive health in people with early onset colorectal cancer. This information will help researchers know more about how cancer treatments affect reproductive and sexual health, including the ability to have children (fertility).

Conditions

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hormone biomarker analysis	For female patients, hormone biomarker analysis will be performed to measure: anti-Mullerian hormone (AMH), estradiol and FSH in the blood. In male patients, hormone biomarkers of testicular function and spermatogenesis will be monitored: testosterone, inhibin B, steroid hormone binding globulin (SHBG) and FSH. Sperm analysis will also be performed in male patients to monitor changes in sperm count.
BEHAVIORAL	QoL Questionnaires	All participants will respond to protocol questionnaires, which will include both validated questionnaires as well as non-validated ones. This design will allow for basic demographic, psychosocial and sexual-health-related data to be obtained.

Timeline

• Start date: 2021-03-18
• Primary completion: 2027-03-18
• Completion: 2027-03-18
• First posted: 2021-03-24
• Last updated: 2026-04-07

Locations

7 sites across 1 country: United States