Delayed Effects of Treatment in Cancer Survivors (DETECS)
| Status: | Withdrawn |
|---|---|
| Conditions: | Breast Cancer, Cervical Cancer, Cancer, Cancer, Blood Cancer, Lymphoma, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/5/2017 |
| Start Date: | March 2014 |
| End Date: | January 2015 |
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.
therapy on young, reproductively aged cancer survivors. The investigators objective is to
characterize some of these effects in the cancer population.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
