NCT00402935

Brief Summary

RATIONALE: Comparing results of diagnostic procedures, such as ultrasound, done before, during, and after chemotherapy may help doctors learn about the side effects of chemotherapy and help plan the best treatment. PURPOSE: This clinical trial is studying ovarian damage in young premenopausal women undergoing chemotherapy for cancer.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

First QC Date

November 21, 2006

Last Update Submit

March 16, 2012

Conditions

LeukemiaLong-term Effects Secondary to Cancer Therapy in AdultsLong-term Effects Secondary to Cancer Therapy in ChildrenLymphomaSexual Dysfunction and InfertilitySexuality and Reproductive IssuesUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

long-term effects secondary to cancer therapy in adultslong-term effects secondary to cancer therapy in childrensexual dysfunction and infertilitysexuality and reproductive issuesadult acute lymphoblastic leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiarecurrent childhood acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemiaadult acute myeloid leukemia in remissionrecurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiauntreated adult acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciessecondary acute myeloid leukemiastage I adult Hodgkin lymphomastage I childhood Hodgkin lymphomastage II adult Hodgkin lymphomastage II childhood Hodgkin lymphomastage III adult Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV adult Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomaunspecified adult solid tumor, protocol specificunspecified childhood solid tumor, protocol specificchildhood acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(8;21)(q22;q22)

Outcome Measures

Primary Outcomes (1)

  • Incidence of ovarian damage after cytotoxic chemotherapy as determined by changes in ovarian volume, antral follicle count, and follicle-stimulating hormone, estradiol, and inhibin B levels

    Ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points.

Interventions

laboratory biomarker analysisOTHER

Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.

fertility assessment and managementPROCEDURE

Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.

management of therapy complicationsPROCEDURE

Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.

ultrasound imagingPROCEDURE

Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.

Eligibility Criteria

Age14 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

premenopausal women undergoing chemotherapy for cancer

DISEASE CHARACTERISTICS: * Diagnosis of cancer, including, but not limited to, any of the following: * Acute lymphocytic leukemia * Acute myeloid leukemia * Hodgkin's lymphoma * Must have primary disease with significant chance for long-term survival after therapy * Scheduled to receive chemotherapeutic agents known to be associated with ovarian failure, including any of the following: * Cyclophosphamide * Mechlorethamine hydrochloride * Busulfan * Procarbazine hydrochloride * Chlorambucil * Melphalan * Ifosfamide * Cisplatin * Carboplatin * Postmenarchal and premenopausal PATIENT CHARACTERISTICS: * Female * Weight ≤ 250 pounds * Not pregnant PRIOR CONCURRENT THERAPY: * No prior or concurrent total-body irradiation or radiotherapy to the pelvis * Concurrent bone marrow transplantation allowed * Concurrent oral contraception and/or gonadotropin releasing-hormone analogue allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.

MeSH Terms

Conditions

LeukemiaLymphomaSexual Dysfunction, PhysiologicalInfertilitySexualityPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteHodgkin DiseaseRecurrenceCongenital Abnormalities

Interventions

TherapeuticsHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesGenital DiseasesUrogenital DiseasesSexual BehaviorBehaviorLeukemia, LymphoidLeukemia, MyeloidDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Marjorie Greenfield, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 23, 2006

Study Start

February 1, 2004

Study Completion

May 1, 2007

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(1)