Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer
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| ClinicalTrials.gov Identifier: NCT04812912 |
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Recruitment Status :
Recruiting
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
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Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
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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).
| Condition or disease | Intervention/treatment |
|---|---|
| Colorectal Cancer Colorectal Neoplasms Colorectal Carcinoma | Diagnostic Test: Hormone biomarker analysis Behavioral: QoL Questionnaires |
| Study Type : | Observational |
| Estimated Enrollment : | 120 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients |
| Actual Study Start Date : | March 18, 2021 |
| Estimated Primary Completion Date : | March 18, 2024 |
| Estimated Study Completion Date : | March 18, 2024 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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Participants with Colon Cancer
This patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis
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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. |
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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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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. |
Primary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04812912
Contacts
| Contact: Andrea Cercek, MD | 646-888-4189 | cerceka@mskcc.org | |
| Contact: Paul Romesser, MD | 646-888-2118 | romessep@mskcc.org |
Locations
| United States, New Jersey | |
| Memorial Sloan Kettering Basking Ridge | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Contact: Andrea Cercek, MD 646-888-4189 | |
| Memorial Sloan Kettering Monmouth | Recruiting |
| Middletown, New Jersey, United States, 07748 | |
| Contact: Andrea Cercek, MD 646-888-4189 | |
| Memorial Sloan Kettering Bergen | Recruiting |
| Montvale, New Jersey, United States, 07645 | |
| Contact: Andrea Cercek, MD 646-888-4189 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center at Suffolk - Commack | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Andrea Cercek, MD 646-888-4189 | |
| Memoral Sloan Kettering Westchester | Recruiting |
| Harrison, New York, United States, 10604 | |
| Contact: Andrea Cercek, MD 646-888-4189 | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Andrea Cercek, MD 646-888-4189 | |
| Memorial Sloan Kettering Nassau | Recruiting |
| Rockville Centre, New York, United States, 11553 | |
| Contact: Andrea Cercek, MD 646-888-4189 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
| Principal Investigator: | Andrea Cercek, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT04812912 |
| Other Study ID Numbers: |
21-035 |
| First Posted: | March 24, 2021 Key Record Dates |
| Last Update Posted: | March 24, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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Early Onset Colorectal Cancer Colorectal Cancer 21-035 Memorial Sloan Kettering Cancer Center |
Additional relevant MeSH terms:
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |