Delayed Effects of Treatment in Cancer Survivors (DETECS)

Breast Cancer Clinical Trial

— DETECS  

Official title:

Delayed Effects of Treatment in Cancer Survivors (DETECS)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02067637
• Other study ID #: 13-1761.cc
• Status: Withdrawn
• Phase: N/A
• First received: February 12, 2014
• Last updated: April 3, 2017
• Start date: March 2014
• Est. completion date: January 2015

Study information

• Verified date: April 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Gynecologic Cancer
• Leukemia
• Lymphoma

Locations

Country	Name	City	State
United States	University of Colorado Clinical and Translational Research Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Colorado Clinical & Translational Sciences Institute

Country where clinical trial is conducted

United States, 

References & Publications (9)

Di Paola R, Costantini C, Tecchio C, Salvagno GL, Montemezzi R, Perandini A, Pizzolo G, Zaffagnini S, Franchi M. Anti-Müllerian 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. — View Citation

Gleeson HK, Shalet SM. Endocrine complications of neoplastic diseases in children and adolescents. Curr Opin Pediatr. 2001 Aug;13(4):346-51. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 May 29. — View Citation

Nandagopal R, Laverdière 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. Epub 2007 Dec 5. Review. — View Citation

Sklar C, Boulad F, Small T, Kernan N. Endocrine complications of pediatric stem cell transplantation. Front Biosci. 2001 Aug 1;6:G17-22. Review. — View Citation

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. — View Citation

Outcome

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