- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02067637
Delayed Effects of Treatment in Cancer Survivors (DETECS) (DETECS)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Kontakte und Standorte
Studienorte
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Clinical and Translational Research Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
---|
Exposed
Individuals with one of the following cancer diagnoses: breast, leukemia, lymphoma, and/or any gynecologic cancer.
|
Unexposed
Healthy controls
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Serum anti-Mullerian hormone (AMH)
Zeitfenster: Day 0 - 1 time measurement
|
Test of ovarian reserve via a blood sample.
|
Day 0 - 1 time measurement
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Body Mass Index (BMI)
Zeitfenster: Day 0 - 1 time measurement
|
Height and weight will be measured to calculate BMI.
|
Day 0 - 1 time measurement
|
Antral Follicle Count
Zeitfenster: Day 0 - 1 time measurement
|
Measure of ovarian reserve via a transvaginal ultrasound.
|
Day 0 - 1 time measurement
|
Hemoglobin A1c
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Day 0 - 1 time measurement
|
We will measure how much vitamin D is present via a blood test.
|
Day 0 - 1 time measurement
|
Estrone
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 0 - 1 time measurement
|
Ovarian volume will be measured via a transvaginal ultrasound.
|
Day 0 - 1 time measurement
|
Quality of Life
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Laxmi Kondapalli, MD, MSCE, University of Colorado, Denver
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 13-1761.cc
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Lymphom
-
SWOG Cancer Research NetworkNational Cancer Institute (NCI); Genentech, Inc.RekrutierungDiffuses großzelliges B-Zell-Lymphom | Wiederkehrendes diffuses großzelliges B-Zell-Lymphom | Refraktäres diffuses großzelliges B-Zell-Lymphom | Primäres mediastinales (thymisches) großes B-Zell-Lymphom | Follikuläres Lymphom Grad 3b | Transformierte follikuläre Lymphe zu Diff Large B-Zell-Lymphom und andere BedingungenVereinigte Staaten