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Observational Study on Reproductive and Sexual Health in Early Onset Colorectal Cancer

This study is looking at how treatments for colorectal cancer, like chemotherapy and radiation, affect your reproductive and sexual health. Researchers will observe and track changes in your hormone levels and your overall sexual and reproductive health. This includes looking at how treatments might impact your ability to have children (fertility). The study is open to men aged 18-50 and premenopausal women aged 18-40 who have been diagnosed with colorectal adenocarcinoma and are eligible for certain cancer treatments. The goal is to understand these effects better, with success measured by changes in specific hormone levels like anti-Mullerian hormone (AMH) in women and testosterone in men, over a period of up to 30 months. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 120 participants. It is not a treatment study but rather observes changes in participants over time.
What's involved
You would provide blood samples for hormone biomarker analysis and complete questionnaires about your basic demographic, psychosocial, and sexual health.
Compensation
Not stated in the trial record.
Follow-up
Your hormone levels will be measured for up to 30 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04812912

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

Recruiting
Not specifiedAges 18–50Observational
Memorial Sloan Kettering Cancer Center
~120 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Hormone biomarker analysisQoL Questionnaires

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y)
Measured over Up to 30 months
+1 more outcome measured

Conditions

Colorectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma

Explore related trials

Colorectal Carcinoma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Andrea Cercek, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Andrea Cercek, MD
[email protected]
646-888-4189
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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 cancerUp to 30 months