Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
Recruiting · NCT01788839 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Blood drawTransvaginal ultrasoundssurveys
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
7 locations listed across 2 US states.
- Memorial Sloan Kettering Basking Ridge - Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth - Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen - Montvale, New Jersey, United States
- Memorial Sloan Kettering Commack - Commack, New York, United States
- Memorial Sloan Kettering Westchester - Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Memorial Sloan Kettering Nassau - Uniondale, New York, United States