Delayed Effects of Treatment in Cancer Survivors (DETECS) (DETECS)
3 april 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Ingetrokken
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado Clinical and Translational Research Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 45 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Exposed
Individuals with one of the following cancer diagnoses: breast, leukemia, lymphoma, and/or any gynecologic cancer.
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Unexposed
Healthy controls
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Serum anti-Mullerian hormone (AMH)
Tijdsspanne: Day 0 - 1 time measurement
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Test of ovarian reserve via a blood sample.
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Day 0 - 1 time measurement
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Body Mass Index (BMI)
Tijdsspanne: Day 0 - 1 time measurement
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Height and weight will be measured to calculate BMI.
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Day 0 - 1 time measurement
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Antral Follicle Count
Tijdsspanne: Day 0 - 1 time measurement
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Measure of ovarian reserve via a transvaginal ultrasound.
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Day 0 - 1 time measurement
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Hemoglobin A1c
Tijdsspanne: Day 0 - 1 time measurement
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Will measure the percentage of hemoglobin that is coated with sugar (glycated).
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Day 0 - 1 time measurement
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High sensitivity C reactive protein (hsCRP)
Tijdsspanne: Day 0 - 1 time measurement
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We will measure low levels of C-reactive protein (CRP) by blood test.
The test will be done to determine risk for heart disease.
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Day 0 - 1 time measurement
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Follicle-stimulating hormone (FSH)
Tijdsspanne: Day 0 - 1 time measurement
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We will measure the amount of follicle-stimulating hormone (FSH) in a blood sample.
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Day 0 - 1 time measurement
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25-OH vitamin D
Tijdsspanne: Day 0 - 1 time measurement
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We will measure how much vitamin D is present via a blood test.
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Day 0 - 1 time measurement
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Estrone
Tijdsspanne: Day 0 - 1 time measurement
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We will measure the amount of estrone (form of estrogen) by testing a urine sample.
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Day 0 - 1 time measurement
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Pregnanediol
Tijdsspanne: Day 0 - 1 time measurement
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We will measure the amount of pregnanediol by testing a urine sample.
This is an indirect way to measure progesterone levels in the body.
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Day 0 - 1 time measurement
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Testosterone
Tijdsspanne: Day 0 - 1 time measurement
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We will measure the amount of the steroid hormone testosterone by testing a blood sample.
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Day 0 - 1 time measurement
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Ovarian volume
Tijdsspanne: Day 0 - 1 time measurement
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Ovarian volume will be measured via a transvaginal ultrasound.
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Day 0 - 1 time measurement
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Quality of Life
Tijdsspanne: Day 0 - 1 time measurement
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Validated instruments will be used to compare quality of life markers between cancer survivors and healthy controls.
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Day 0 - 1 time measurement
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Laxmi Kondapalli, MD, MSCE, University of Colorado, Denver
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 maart 2014
Primaire voltooiing (Werkelijk)
1 januari 2015
Studie voltooiing (Werkelijk)
1 januari 2015
Studieregistratiedata
Eerst ingediend
12 februari 2014
Eerst ingediend dat voldeed aan de QC-criteria
18 februari 2014
Eerst geplaatst (Schatting)
20 februari 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 april 2017
Laatste update ingediend die voldeed aan QC-criteria
3 april 2017
Laatst geverifieerd
1 april 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 13-1761.cc
Plan Individuele Deelnemersgegevens (IPD)
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