Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Children's Oncology Group
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01793233
First received: February 13, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

This clinical trial studies blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.


Condition Intervention
Non Hodgkins Lymphoma
Hodgkins Disease
Other: questionnaire administration
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of healthy controls [ Time Frame: 12 months post therapy ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Describe acute ovarian failure (AOF) prevalence 12 months post-therapy [ Time Frame: 12 months post therapy ] [ Designated as safety issue: No ]
    Describe the rate of acute ovarian failure (amenorrhea plus FSH and E2) at 12 months post-therapy. With 195-205 enrolled case patients the uncertainty in the estimates of the ovarian failure rate at 12 months post-therapy would be at most ± 5%.

  • Degree of recovery of AMH, FSH, and E2 in the post-therapy phase [ Time Frame: 12 months post therapy ] [ Designated as safety issue: No ]
    Generalized estimating equation (GEE) will be used to model the change as a function of time.

  • Rate of AOF [ Time Frame: 12 months post therapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Collect blood samples for future evaluation of drug metabolizing enzyme polymorphisms.


Estimated Enrollment: 205
Study Start Date: February 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Health services research (menstrual diary, biomarker analysis)
Patients complete a menstrual diary to document vaginal bleeding (questionnaire administration), complete a medication log 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 for laboratory biomarker analysis.
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

The primary objectives of this study are to compare Anti Mullerian Hormone (AMH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) between patients (enrolled groupwide) at two timepoints (baseline and 12 months off therapy) and a cross section of controls (enrolled at limited institutions) and to describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Female adolescents with Lymphoma

Criteria

Inclusion Criteria:

  • 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: ie procarbazine, cyclophosphamide, ifosphamide. Planned cancer treatment must be less than one year.
  • Patients with any performance status are eligible for enrollment
  • Patients may take oral contraceptives

Exclusion Criteria:

  • Patients who have previously received chemotherapy other than steroids
  • Patients who have a secondary malignancy are not eligible
  • Patients with known history of ovarian disease: e.g. Turner Syndrome or Polycystic Ovarian Syndrome
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793233

Contacts
Contact: Jennifer M Levine, MD, MSW 212 305-5808 jl175@columbia.edu

  Show 21 Study Locations
Sponsors and Collaborators
Children's Oncology Group
The Leukemia and Lymphoma Society
Investigators
Study Chair: Jennifer M Levine, MD, MSW Columbia University
Principal Investigator: Jennifer Levine Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01793233     History of Changes
Other Study ID Numbers: ALTE11C1, NCI-2013-00069, COG-ALTE11C1
Study First Received: February 13, 2013
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Oncology Group:
Non Hodgkins Lymphoma
Hodgkins Disease
Late Effects

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014