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Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

21 Years
Not Enrolling
Non Hodgkins Lymphoma, Hodgkins Disease

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Trial Information

Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

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.

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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of healthy controls

Outcome Description:

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.

Outcome Time Frame:

12 months post therapy

Safety Issue:


Principal Investigator

Jennifer M Levine, MD, MSW

Investigator Role:

Study Chair

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

February 2013

Completion Date:

Related Keywords:

  • Non Hodgkins Lymphoma
  • Hodgkins Disease
  • Non Hodgkins Lymphoma
  • Hodgkins Disease
  • Late Effects
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin