Delayed Effects of Treatment in Cancer Survivors (DETECS)

University of Colorado Denver (CU Denver)

Status: Withdrawn

Conditions: Breast Cancer; Gynecologic Cancer; Lymphoma; Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT02067637

13-1761.cc

Details and patient eligibility

About

Hypotheses and Specific Aims: There is limited data on the long-term consequences of cancer therapy on young, reproductively aged cancer survivors. The investigators objective is to characterize some of these effects in the cancer population.

Full description

Specific Aim 1: To compare markers of ovarian reserve between cancer survivors and healthy controls.

Hypothesis: Cancer survivors will have lower serum Anti-Mullerian Hormone (AMH) and antral follicle count (AFC), and higher Follicle Stimulating Hormone (FSH) than healthy controls.

Specific Aim 2: To compare cardio-metabolic, endocrine and bone profiles between cancer survivors and controls using a combination of anthropometric measures, fasting serum markers, and urinary markers of bone health.

Hypothesis: Cancer survivors will have higher total cholesterol and lower 25-OH vitamin D than healthy controls.

Specific Aim 3: To evaluate potential associations between ovarian reserve and markers of metabolism, obesity, and tumor bone health in young female cancer survivors.

Hypothesis: As BMI and total cholesterol increases, serum AMH will decrease.

Specific Aim 4: To compare quality of life markers, as assessed by validated instruments, between cancer survivors and controls using recommended scoring techniques.

Hypothesis: Cancer survivors will have lower quality of life markers as compared to controls.

The investigators will conduct a prospective study to characterize the quality of life and cardio-metabolic, endocrine, and bone profiles of female cancer survivors using a combination of anthropometric, serum, urinary, and ultrasonographic markers in combination with QOL instruments.

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Exposed: Females between the ages of 18 and 45, at least 2 years from the completion of cancer therapy. Subjects will have one of the following cancer diagnoses: breast, leukemia, lymphoma, and/or any gynecologic cancer. Subjects must also be postmenarchal, have a uterus, at least one intact ovary, and must be willing and able to comply with study procedures. Subjects can be of any menopausal status and within 10 years post treatment.
• Unexposed: Females between the ages of 18 and 45 with no prior history of cancer treatment.

Exclusion criteria

• Exposed: Pregnancy, lactation within the previous 3 months, any medical condition other than cancer with a known correlation with premature menopause (i.e. Turner's syndrome, Fragile X, gonadal dysgenesis, polyglandular autoimmune syndrome, lupus, etc.), hormonal contraceptive use within 3 months.
• Unexposed: Healthy controls with a history of polycystic ovary syndrome (PCOS), diabetes, thyroid dysfunction, hypertension, and hypercholesterolemia will be excluded in addition to cancer patients or survivors with one of the aforementioned diseases diagnosed prior to cancer diagnosis or treatment.

Trial design

0 participants in 2 patient groups

Exposed

Description:

Individuals with one of the following cancer diagnoses: breast, leukemia, lymphoma, and/or any gynecologic cancer.

Unexposed

Description:

Healthy controls