Delayed Effects of Treatment in Cancer Survivors (DETECS) (DETECS)

April 3, 2017 updated by: University of Colorado, Denver
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.

Study Overview

Status

Withdrawn

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Clinical and Translational Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Exposed
Individuals with one of the following cancer diagnoses: breast, leukemia, lymphoma, and/or any gynecologic cancer.
Unexposed
Healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum anti-Mullerian hormone (AMH)
Time Frame: Day 0 - 1 time measurement
Test of ovarian reserve via a blood sample.
Day 0 - 1 time measurement

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laxmi Kondapalli, MD, MSCE, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 13-1761.cc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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