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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04812912
Other study ID # 21-035
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 18, 2021
Est. completion date March 18, 2025

Study information

Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Andrea Cercek, MD
Phone 646-888-4189
Email cerceka@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 18, 2025
Est. primary completion date March 18, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Cancer Center at Suffolk - Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Hartford Healthcare Cancer Alliance (Data collection only) Hartford Connecticut
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau Rockville Centre New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y) Up to 30 months
Primary 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
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