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AzTrials

Breast CancerDETECSNCT02067637

Delayed Effects of Treatment in Cancer Survivors (DETECS)

An observational study of Breast Cancer and Leukemia, run by University of Colorado, Denver at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Leukemia, Lymphoma
How many people
0 participants
Where
1 siteUnited States
Study dates
Mar 2014to Jan 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Clinical and Translational Research Center

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the 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.

Keywords
cancer therapy, cancer treatment
Medical subject headings
Breast Neoplasms, Leukemia, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02067637
Study groupRoleWhat they receive
ExposedIndividuals with one of the following cancer diagnoses: breast, leukemia, lymphoma, and/or any gynecologic cancer.
UnexposedHealthy controls

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum anti-Mullerian hormone (AMH)

    Test of ovarian reserve via a blood sample.

    Measured: Day 0 - 1 time measurement

Secondary outcomes (11)

  1. Body Mass Index (BMI)

    Height and weight will be measured to calculate BMI.

    Measured: Day 0 - 1 time measurement

  2. Antral Follicle Count

    Measure of ovarian reserve via a transvaginal ultrasound.

    Measured: Day 0 - 1 time measurement

  3. Hemoglobin A1c

    Will measure the percentage of hemoglobin that is coated with sugar (glycated).

    Measured: Day 0 - 1 time measurement

  4. High sensitivity C reactive protein (hsCRP)

    We will measure low levels of C-reactive protein (CRP) by blood test. The test will be done to determine risk for heart disease.

    Measured: Day 0 - 1 time measurement

  5. Follicle-stimulating hormone (FSH)

    We will measure the amount of follicle-stimulating hormone (FSH) in a blood sample.

    Measured: Day 0 - 1 time measurement

  6. 25-OH vitamin D

    We will measure how much vitamin D is present via a blood test.

    Measured: Day 0 - 1 time measurement

  7. Estrone

    We will measure the amount of estrone (form of estrogen) by testing a urine sample.

    Measured: Day 0 - 1 time measurement

  8. Pregnanediol

    We will measure the amount of pregnanediol by testing a urine sample. This is an indirect way to measure progesterone levels in the body.

    Measured: Day 0 - 1 time measurement

  9. Testosterone

    We will measure the amount of the steroid hormone testosterone by testing a blood sample.

    Measured: Day 0 - 1 time measurement

  10. Ovarian volume

    Ovarian volume will be measured via a transvaginal ultrasound.

    Measured: Day 0 - 1 time measurement

  11. Quality of Life

    Validated instruments will be used to compare quality of life markers between cancer survivors and healthy controls.

    Measured: Day 0 - 1 time measurement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02067637
Sponsor's protocol ID
13-1761.cc
Acronym
DETECS
Status last verified
Apr 2017
First submitted
12 Feb 2014
Last updated
4 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Iughetti L, Bruzzi P, Predieri B, Paolucci P. Obesity in patients with acute lymphoblastic leukemia in childhood. Ital J Pediatr. 2012 Jan 27;38:4. doi: 10.1186/1824-7288-38-4.

    PubMed 22284631

  • Landy DC, Miller TL, Lopez-Mitnik G, Lipsitz SR, Hinkle AS, Constine LS, French CA, Rovitelli AM, Adams MJ, Lipshultz SE. Aggregating traditional cardiovascular disease risk factors to assess the cardiometabolic health of childhood cancer survivors: an analysis from the Cardiac Risk Factors in Childhood Cancer Survivors Study. Am Heart J. 2012 Feb;163(2):295-301.e2. doi: 10.1016/j.ahj.2011.11.008.

    PubMed 22305850

  • Nandagopal R, Laverdiere C, Mulrooney D, Hudson MM, Meacham L. Endocrine late effects of childhood cancer therapy: a report from the Children's Oncology Group. Horm Res. 2008;69(2):65-74. doi: 10.1159/000111809. Epub 2007 Dec 5.

    PubMed 18059086

  • Sklar C, Boulad F, Small T, Kernan N. Endocrine complications of pediatric stem cell transplantation. Front Biosci. 2001 Aug 1;6:G17-22. doi: 10.2741/a714.

    PubMed 11487479

  • Gleeson HK, Shalet SM. Endocrine complications of neoplastic diseases in children and adolescents. Curr Opin Pediatr. 2001 Aug;13(4):346-51. doi: 10.1097/00008480-200108000-00011.

    PubMed 11717561

  • Toner JP, Philput CB, Jones GS, Muasher SJ. Basal follicle-stimulating hormone level is a better predictor of in vitro fertilization performance than age. Fertil Steril. 1991 Apr;55(4):784-91. doi: 10.1016/s0015-0282(16)54249-6.

    PubMed 1901282

  • Lee MM, Donahoe PK, Hasegawa T, Silverman B, Crist GB, Best S, Hasegawa Y, Noto RA, Schoenfeld D, MacLaughlin DT. Mullerian inhibiting substance in humans: normal levels from infancy to adulthood. J Clin Endocrinol Metab. 1996 Feb;81(2):571-6. doi: 10.1210/jcem.81.2.8636269.

    PubMed 8636269

  • Di Paola R, Costantini C, Tecchio C, Salvagno GL, Montemezzi R, Perandini A, Pizzolo G, Zaffagnini S, Franchi M. Anti-Mullerian hormone and antral follicle count reveal a late impairment of ovarian reserve in patients undergoing low-gonadotoxic regimens for hematological malignancies. Oncologist. 2013;18(12):1307-14. doi: 10.1634/theoncologist.2013-0138. Epub 2013 Oct 22.

    PubMed 24149138

  • Lutchman Singh K, Muttukrishna S, Stein RC, McGarrigle HH, Patel A, Parikh B, Groome NP, Davies MC, Chatterjee R. Predictors of ovarian reserve in young women with breast cancer. Br J Cancer. 2007 Jun 18;96(12):1808-16. doi: 10.1038/sj.bjc.6603814. Epub 2007 May 29.

    PubMed 17533402

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Leukemia, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum anti-Mullerian hormone (AMH) (time frame: Day 0 - 1 time measurement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02067637, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.

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