Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hormone biomarker analysis
Diagnostic testFor 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
BehavioralAll 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Participants with Colon Cancer2 interventions
Group B: Participants with Rectal Cancer2 interventions
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov