Trials / Withdrawn
WithdrawnNCT02067637
Delayed Effects of Treatment in Cancer Survivors (DETECS)
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2014-02-20
- Last updated
- 2017-04-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02067637. Inclusion in this directory is not an endorsement.