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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE-CWRU-3803 | Other Identifier | Case Comprehensive Cancer Center | |
| CASE-01-04-15 |
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slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a pilot, prospective study.
Patients undergo a transvaginal or transabdominal 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 for follicle-stimulating hormone, estradiol, and inhibin B levels. 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.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels. | ||
| fertility assessment and management | Procedure | Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles. | ||
| management of therapy complications | Procedure | 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 imaging | Procedure | Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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DISEASE CHARACTERISTICS:
Diagnosis of cancer, including, but not limited to, any of the following:
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:
Postmenarchal and premenopausal
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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premenopausal women undergoing chemotherapy for cancer
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| Name | Affiliation | Role |
|---|---|---|
| Marjorie Greenfield, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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Blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D012735 | Sexual Dysfunction, Physiological |
| D007246 | Infertility |
| D019529 | Sexuality |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D006689 | Hodgkin Disease |
| D012008 | Recurrence |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D007945 | Leukemia, Lymphoid |
| D007951 | Leukemia, Myeloid |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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