Delayed Effects of Treatment in Cancer Survivors (DETECS) (DETECS)
3 avril 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Retiré
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Clinical and Translational Research Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 45 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Serum anti-Mullerian hormone (AMH)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body Mass Index (BMI)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Laxmi Kondapalli, MD, MSCE, University of Colorado, Denver
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mars 2014
Achèvement primaire (Réel)
1 janvier 2015
Achèvement de l'étude (Réel)
1 janvier 2015
Dates d'inscription aux études
Première soumission
12 février 2014
Première soumission répondant aux critères de contrôle qualité
18 février 2014
Première publication (Estimation)
20 février 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 avril 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 avril 2017
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 13-1761.cc
Plan pour les données individuelles des participants (IPD)
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