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

Conditions

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Hormone biomarker analysis — DIAGNOSTIC_TEST
  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.
• QoL Questionnaires — BEHAVIORAL
  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.

Study Details

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).

Key Dates

Start date

Mar 18, 2021

Status verified

Apr 2026

Primary completion

Mar 18, 2027

Completion

Mar 18, 2027

Study Design

Enrollment

120 participants (estimated)

Arms

• Arm: Participants with Colon Cancer
  This patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis
• Arm: Participants with Rectal Cancer
  This patient population will have hormone biomarker analysis, QOL administration, and, if the patient is male, semen analysis

Primary Outcome Measure

Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y) [ Time Frame: Up to 30 months ]

Central Contacts

• Andrea Cercek, MD
  646-888-4189
  [email protected]
• Paul Romesser, MD
  646-888-2118
  [email protected]

Locations (7)

Find similar trials in Basking Ridge, NJ

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