Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04812912

Conditions

Colorectal Cancer

Colorectal Neoplasms

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Hormone biomarker analysis

QoL Questionnaires

Study Details

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).

Conditions

Colorectal Cancer

Colorectal Neoplasms

Colorectal Carcinoma

Study ID

NCT04812912

Start date

Mar 18, 2021

Status verified date

Apr, 2026

Completion date

Mar 18, 2027

Anticipated

Primary completion date

Mar 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

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 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Andrea Cercek, MD

646-888-4189cerceka@mskcc.org

Paul Romesser, MD

646-888-2118romessep@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Cancer Center at Suffolk - Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Nassau

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Andrea Cercek, MD

646-888-4189

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • Early Onset Colorectal Cancer
  • Colorectal Cancer
  • 21-035
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-07.