NCT01788839 Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
| NCT ID | NCT01788839 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 475 participants |
| Start Date | 2013-02 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 475 participants in total. It began in 2013-02 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to see how cancer treatment affects sexual and reproductive function. The patient will also be asked to participate in blood draws to see if and how cancer treatment affects the ovaries and the ability to have children (fertility). These blood draws are optional and the patient can still participate in the questionnaire portion of the study even if they choose not to have their blood drawn.
Eligibility Criteria
Inclusion Criteria: Subject Inclusion Criteria for Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma * Women, 18 years of age and older * Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months * Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months. * Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent. * Breast cancer patients with any receptor type * English speaking * Able to participate in the informed consent process Subject Inclusion Criteria for Tamoxifen Only Subset of Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma * Women, 18 years of age and older. * Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months * Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months. * Women with newly diagnosed breast cancer (stage 0-III) who have not yet started treatment and are planning to start Tamoxifen as their only form of systemic treatment within one month * Breast cancer patients with any receptor type * English speaking * Able to participate in the informed consent process Subject Inclusion Criteria for Cohort of Postmenopausal Women with Early Stage Breast Cancer and Lymphoma * Women, 18 years of age and older. * Postmenopausal women at time of diagnosis who have been without period for ≥ 2 years. * Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent. * Breast cancer patients with any receptor type * English speaking * Able to participate in the informed consent process Exclusion Criteria: Subject Exclusion Criteria for both Pre and Postmenopausal Women with Early Stage Breast Cancer and Lymphoma * Active secondary cancer requiring cytotoxic chemotherapy * Prior systemic treatment for a malignancy
Contact & Investigator
Shari Goldfarb, MD
📞 646-888-5080
Shari Goldfarb, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT01788839 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01788839 currently recruiting?
Yes, NCT01788839 is actively recruiting participants. Visit ClinicalTrials.gov or contact Memorial Sloan Kettering Cancer Center to inquire about joining.
Where is the NCT01788839 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT01788839 clinical trial?
NCT01788839 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Shari Goldfarb, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 475 participants.
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