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Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how cancer treatment affects sexual health and the ability to have children in women with breast cancer or lymphoma. Women answer questions and may choose to have blood tests to check how treatment affects their ovaries, which hold eggs. The blood tests are optional.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Speak English and can take part in the process of understanding and agreeing to the study.
  • Have newly diagnosed stage 0–III breast cancer and be within 1 month of starting treatment that works throughout the body; or have fast-growing lymphoma, a cancer of the immune system, receiving its first treatment with the goal of a cure.
  • Women with breast cancer may have any receptor type—markers that help guide treatment.
  • For the group before menopause: at diagnosis, have been pregnant or had at least one period in the past 12 months. Women who do not meet this rule may join only if they had an IUD, a birth control device in the uterus, within the past 12 months.
  • For the group after menopause: at diagnosis, have had no periods for at least 2 years.
  • For the tamoxifen-only group: meet the rules for women before menopause, have newly diagnosed stage 0–III breast cancer, and have not started treatment. Plan to start tamoxifen within 1 month as the only treatment that works throughout the body.

Who can't join

  • Have another active cancer that needs chemotherapy that kills cells.
  • Have had treatment that works throughout the body for a previous cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (7)

NJ

NY