Delayed Effects of Treatment in Cancer Survivors (DETECS)

Withdrawn

• Conditions: Leukemia; Breast Cancer; Lymphoma; Gynecologic Cancer

• Registration Number: NCT02067637
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-20
• Study Start: 2014-03
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum anti-Mullerian hormone (AMH)	Day 0 - 1 time measurement	Test of ovarian reserve via a blood sample.

Secondary Outcome Measures

Name	Time	Method
High sensitivity C reactive protein (hsCRP)	Day 0 - 1 time measurement	We will measure low levels of C-reactive protein (CRP) by blood test. The test will be done to determine risk for heart disease.
25-OH vitamin D	Day 0 - 1 time measurement	We will measure how much vitamin D is present via a blood test.
Antral Follicle Count	Day 0 - 1 time measurement	Measure of ovarian reserve via a transvaginal ultrasound.
Body Mass Index (BMI)	Day 0 - 1 time measurement	Height and weight will be measured to calculate BMI.
Hemoglobin A1c	Day 0 - 1 time measurement	Will measure the percentage of hemoglobin that is coated with sugar (glycated).
Follicle-stimulating hormone (FSH)	Day 0 - 1 time measurement	We will measure the amount of follicle-stimulating hormone (FSH) in a blood sample.
Estrone	Day 0 - 1 time measurement	We will measure the amount of estrone (form of estrogen) by testing a urine sample.
Pregnanediol	Day 0 - 1 time measurement	We will measure the amount of pregnanediol by testing a urine sample. This is an indirect way to measure progesterone levels in the body.
Testosterone	Day 0 - 1 time measurement	We will measure the amount of the steroid hormone testosterone by testing a blood sample.
Ovarian volume	Day 0 - 1 time measurement	Ovarian volume will be measured via a transvaginal ultrasound.
Quality of Life	Day 0 - 1 time measurement	Validated instruments will be used to compare quality of life markers between cancer survivors and healthy controls.

Trial Locations

Locations (1)

University of Colorado Clinical and Translational Research Center; 🇺🇸 Aurora, Colorado, United States