Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas
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|ClinicalTrials.gov Identifier: NCT01793233|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : January 12, 2023
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|Condition or disease||Intervention/treatment|
|Anaplastic Large Cell Lymphoma Burkitt Lymphoma Diffuse Large B-Cell Lymphoma Hodgkin Lymphoma Lymphoma||Other: Laboratory Biomarker Analysis Other: Questionnaire Administration|
I. Compare anti mullerian hormone (AMH), follicle stimulating hormone (FSH), and estradiol (E2) between patients at baseline and cross section of controls and again between patients at 12 months off therapy and cross section of controls.
II. Describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.
III. Evaluate degree of change of AMH/FSH/E2 from baseline to end of therapy in patients.
IV. Evaluate degree of recovery of AMH/FSH/E2 from end of therapy to 12 months off therapy.
I. Describe acute ovarian failure (AOF) prevalence 12 months post-therapy. II. Collect blood samples for future evaluation of drug metabolizing enzyme polymorphisms.
Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collection at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.
|Study Type :||Observational|
|Actual Enrollment :||203 participants|
|Official Title:||Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma|
|Actual Study Start Date :||June 17, 2013|
|Actual Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Ancillary-Correlative (menstrual diary, biomarker analysis)
Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collections at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
- Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls [ Time Frame: Up to 12 months ]Compared using the Wilcoxon rank-sum test or the two sample t-test after appropriate transformation. Analysis of covariance will be used to adjust these comparisons for covariates including age, race, dose of alkylating agent and use of hormone medications.
- Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline [ Time Frame: Baseline up to end of chemotherapy ]Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.
- Degree of recovery of AMH, FSH, and E2 in the post-therapy phase [ Time Frame: Up to 12 months ]Generalized estimating equation (GEE) will be used to model the change as a function of time.
- Rate of AOF [ Time Frame: Up to 12 months ]Describe the number of patients with AOF as measured at 12 months by an FSH > 40 divided by the total population.
- Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms [ Time Frame: At enrollment (or diagnosis) and Day 5 post enrollment ]Describe the number of samples collected.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||up to 29 Years (Child, Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Patients must have had first menses >= 6 months prior to enrollment
- Patients must be newly diagnosed with lymphoma; this includes but is not limited to Hodgkin lymphoma, Burkitts lymphoma, diffuse large B cell lymphoma, and anaplastic large cell lymphoma
- Planned cancer treatment must include an alkylating agent: i.e. procarbazine, cyclophosphamide, ifosphamide; planned cancer treatment must be less than one year
- Patients with any performance status are eligible for enrollment
- Patients may take hormone medications excluding gonadotropin-releasing hormone (GnRH) analogues
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
- Patients who have previously received chemotherapy other than steroids and intrathecal chemotherapy are not eligible
- Patients who have a secondary malignancy are not eligible
- Patients with known history of ovarian disease: e.g. Turner syndrome or polycystic ovarian syndrome are not eligible
- Patients in whom planned therapy includes: removal or uterus or ovary(ies), pelvic irradiation, cranial irradiation or hematopoietic stem cell transplantation are not eligible
- Patients who previously have had their uterus or ovary(ies) removed are not eligible
- Patients who have received gonadotropin release hormone agonist or antagonist (e.g. Lupron) prior to study entry are not eligible
- Patients who are pregnant or breast feeding are not eligible
- Patients who have undergone or are planning to undergo ovarian tissue, oocyte or embryo cryopreservation prior to treatment are not eligible
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793233
|Principal Investigator:||Jennifer M Levine||Children's Oncology Group|
|Responsible Party:||Children's Oncology Group|
|Other Study ID Numbers:||
NCI-2013-00069 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ALTE11C1 ( Other Identifier: Children's Oncology Group )
COG-ALTE11C1 ( Other Identifier: DCP )
ALTE11C1 ( Other Identifier: CTEP )
U10CA095861 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
|First Posted:||February 15, 2013 Key Record Dates|
|Last Update Posted:||January 12, 2023|
|Last Verified:||January 2023|
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Immune System Diseases
Epstein-Barr Virus Infections
DNA Virus Infections
Tumor Virus Infections