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
1 other identifier
observational
120
1 country
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2021
CompletedStudy Start
First participant enrolled
March 18, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2026
CompletedOctober 24, 2025
October 1, 2025
5 years
March 18, 2021
October 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y)
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
Up to 30 months
Study Arms (2)
Participants with Colon Cancer
This patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis
Participants with Rectal Cancer
This patient population will have hormone biomarker analysis, QOL administration, and, if the patient is male, semen analysis
Interventions
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.
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.
Eligibility Criteria
Potential research subjects will be identified through the Center for Young Onset Colorectal Cancer, a member of the patient's treatment team, the principal investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC). All study participants will be recruited from patients under the care of consenting professionals. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center at Suffolk - Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Cercek, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2021
First Posted
March 24, 2021
Study Start
March 18, 2021
Primary Completion
March 18, 2026
Study Completion
March 18, 2026
Last Updated
October 24, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.