Clinical trial NCT02067637: Delayed Effects of Treatment in Cancer Survivors (DETECS)
Official title: Delayed Effects of Treatment in Cancer Survivors (DETECS)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Leukemia
Lymphoma
Gynecologic Cancer
Keywords: cancer therapy, cancer treatment
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
First posted: 2014-02-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective cohort study of female cancer survivors who are at least 2 years from completion of cancer therapy and healthy controls age less than 45 years.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum anti-Mullerian hormone (AMH)
timeFrame: Day 0 - 1 time measurement
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Day 0 - 1 time measurement
measure: Antral Follicle Count
timeFrame: Day 0 - 1 time measurement
measure: Hemoglobin A1c
timeFrame: Day 0 - 1 time measurement
measure: High sensitivity C reactive protein (hsCRP)
timeFrame: Day 0 - 1 time measurement
measure: Follicle-stimulating hormone (FSH)
timeFrame: Day 0 - 1 time measurement
measure: 25-OH vitamin D
timeFrame: Day 0 - 1 time measurement
measure: Estrone
timeFrame: Day 0 - 1 time measurement
measure: Pregnanediol
timeFrame: Day 0 - 1 time measurement
measure: Testosterone
timeFrame: Day 0 - 1 time measurement
measure: Ovarian volume
timeFrame: Day 0 - 1 time measurement
measure: Quality of Life
timeFrame: Day 0 - 1 time measurement
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Clinical and Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Laxmi Kondapalli, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
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