Colorectal CancerNCT04812912
Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer
An observational study of Colorectal Cancer and Colorectal Neoplasms, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma
- What is being tested?
- Hormone biomarker analysis and QoL Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Mar 2021to 18 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Cancer Center at Suffolk - Commack
Commack, New York, 11725
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Nassau
Rockville Centre, New York, 11553
Andrea Cercek, MD, 646-888-4189
About this study
Official title: The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients
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).
- Being tested
- Hormone biomarker analysis, QoL Questionnaires
- Keywords
- Early Onset Colorectal Cancer, Colorectal Cancer, 21-035, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone biomarker analysisDiagnostic test
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 QuestionnairesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Colon Cancer | This patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis Receives: Diagnostic Test: Hormone biomarker analysis; Behavioral: QoL Questionnaires | |
| Participants with Rectal Cancer | This patient population will have hormone biomarker analysis, QOL administration, and, if the patient is male, semen analysis Receives: Diagnostic Test: Hormone biomarker analysis; Behavioral: QoL Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y)
Measured: 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
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start18 Mar 2021
- Primary completion18 Mar 2027 (estimated)
- Study completion18 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Cercek, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812912
- Sponsor's protocol ID
- 21-035
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2021
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT04812912
- Acronym / sponsor ID
- 21-035
- Keywords
- Early Onset Colorectal Cancer, Colorectal Cancer, 21-035, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 18 Mar 2027 (estimated)
- Study completion
- 18 Mar 2027 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Colon Cancer | – | Diagnostic Test: Hormone biomarker analysis, Behavioral: QoL QuestionnairesThis patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis |
| Participants with Rectal Cancer | – | Diagnostic Test: Hormone biomarker analysis, Behavioral: QoL QuestionnairesThis patient population will have hormone biomarker analysis, QOL administration, and, if the patient is male, semen analysis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormone biomarker analysisFor 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. | Diagnostic test | Participants with Colon Cancer, Participants with Rectal Cancer |
| QoL QuestionnairesAll 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. | Behavioural | Participants with Colon Cancer, Participants with Rectal Cancer |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Cercek, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Neoplasms, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Cercek, MD (646-888-4189, cerceka@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.