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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hormone biomarker analysis | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Cercek, MD | Contact | 646-888-4189 | cerceka@mskcc.org | |
| Paul Romesser, MD | Contact | 646-888-2118 | romessep@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Cercek, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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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| QoL Questionnaires | Behavioral | 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. |
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| Memorial Sloan Kettering Monmouth | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Cancer Center at Suffolk - Commack | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau | Recruiting | Rockville Centre | New York | 11553 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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