Menu
Recruiting NCT04812912

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

— Observational Colorectal Cancer Colorectal Neoplasms Colorectal Carcinoma

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
The protocol lists: Hormone biomarker analysis, QoL Questionnaires.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma. Basic parameters: 18 years — 50 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

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • 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]
  • Change in testosterone, inhibin B, steroid hormone binding globulin (SHBG) and FSH in young male patients (<50y) undergoing therapy for colorectal cancer [Time frame: Up to 30 months]

Eligibility criteria

Inclusion criteria

  • 18-40 years of age and premenopausal (female) or 18-50 years of age (male) at time of diagnosis
  • Histologic diagnosis of colorectal adenocarcinoma
  • Able and willing to participate in the informed consent process
  • Eligible for curative adjuvant or neoadjuvant therapy for colon or rectal cancer
  • Willing and able to complete protocol questionnaires
  • Rectal patients only: Individuals who will be receiving chemotherapy, followed by chemoradiotherapy (ChemoRT)

Exclusion criteria

  • Prior systemic treatment for this malignancy
  • Active or prior secondary malignancy
  • History of ovarian resection (if female)
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test.

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 · 7 centers
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge
  • Memorial Sloan Kettering Monmouth — Middletown
  • Memorial Sloan Kettering Bergen — Montvale
  • Memorial Sloan Kettering Cancer Center at Suffolk - Commack — Commack
  • Memorial Sloan Kettering Westchester — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau — Rockville Centre

Identifiers

NCT: NCT04812912 · 21-035

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗