Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Infectious Disease, Lymphoma, Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Immunology / Infectious Diseases, Oncology |
Healthy: | No |
Age Range: | Any - 29 |
Updated: | 8/9/2018 |
Start Date: | June 17, 2013 |
Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma
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.
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.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
I. Describe acute ovarian failure (AOF) prevalence 12 months post-therapy. II. Collect blood
samples for future evaluation of drug metabolizing enzyme polymorphisms.
OUTLINE:
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.
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.
SECONDARY OBJECTIVES:
I. Describe acute ovarian failure (AOF) prevalence 12 months post-therapy. II. Collect blood
samples for future evaluation of drug metabolizing enzyme polymorphisms.
OUTLINE:
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.
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: 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
Exclusion Criteria:
- 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
We found this trial at
98
sites
New York Medical College The College was founded in 1860 by a group of New...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946

University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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4900 Mueller Boulevard
Austin, Texas 78723
Austin, Texas 78723
(512) 324-0000

Dell Children's Medical Center of Central Texas Welcome to Dell Children
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Children's Hospital of Alabama Children
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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11100 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 844-1000

Principal Investigator: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000

Principal Investigator: Mark A. Ranalli
Phone: 614-722-2708
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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1200 Pleasant Street
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-KIDS

Principal Investigator: Wendy L. Woods-Swafford
Phone: 515-241-6729
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
616.391.9000

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Phone: 616-267-1925
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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282 Washington St
Hartford, Connecticut 06106
Hartford, Connecticut 06106
(860) 545-9000

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Phone: 860-545-9981
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000

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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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1800 West Charleston Boulevard
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262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
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Pensacola, Florida 32504
Pensacola, Florida 32504
(850) 505-4700

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South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000

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Phone: 215-590-2810
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325

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Phone: 412-692-5573
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311

Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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401 College Street
Richmond, Virginia 23298
Richmond, Virginia 23298
(804) 828-0450

Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000

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Phone: 210-567-0653
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7700 Floyd Curl Dr
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San Antonio, Texas 78229
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Wilmington, Delaware 19803
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Atlanta, Georgia 30322
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Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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100 E Idaho St
Boise, Idaho 83712
Boise, Idaho 83712
(208) 381-2711

Principal Investigator: Eugenia Chang
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Phone: 718-904-2730
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5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
1-773-702-6180

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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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4160 John R St #2122
Detroit, Michigan 48201
Detroit, Michigan 48201
(313) 833-1785

Principal Investigator: Meret Henry
Phone: 313-576-9363
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Fort Myers, Florida 33908
Principal Investigator: Emad K. Salman
Phone: 239-343-5333
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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1001 E 5th St
Greenville, North Carolina 27858
Greenville, North Carolina 27858
(252) 328-6131

Principal Investigator: George E. Hucks
Phone: 252-744-2391
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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900 West Faris Rd.
Greenville, South Carolina 29605
Greenville, South Carolina 29605
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BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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30 Prospect Ave
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-2000

Principal Investigator: Burton E. Appel
Phone: 201-996-2879
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1319 Punahou St
Honolulu, Hawaii 96826
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Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 944-5000

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Phone: 317-274-2552
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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2018 W Clinch Ave
Knoxville, Tennessee 37916
Knoxville, Tennessee 37916
(865) 541-8000

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Phone: 865-541-8266
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Phone: 702-384-0013
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Las Vegas, Nevada 89144
Principal Investigator: Jonathan Bernstein
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601 South Rancho Drive
Suite C-26
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(702) 384-0013

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Phone: 702-384-0013
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400

Principal Investigator: Kenneth B. DeSantes
Phone: 608-262-5223
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000

Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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2525 Chicago Ave
Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
(612) 813-6000

Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458

Principal Investigator: Rene Y. McNall-Knapp
Phone: 405-271-4272
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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13535 Nemours Parkway
Orlando, Florida 32827
Orlando, Florida 32827
(407) 567-4000

Principal Investigator: Ramamoorthy Nagasubramanian
Phone: 407-650-7150
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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725 Welch Rd
Palo Alto, California 94304
Palo Alto, California 94304
(650) 497-8000

Principal Investigator: Neyssa M. Marina
Phone: 650-498-7061
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
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Saint Christopher's Hospital for Children St. Christopher's Hospital for Children offers a wide range of...
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2801 N Gantenbein Ave
Portland, Oregon 97227
Portland, Oregon 97227
(503) 276-6500

Legacy Emanuel Children's Hospital For generations our children's hospital has provided outstanding care for kids...
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4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000

Principal Investigator: Douglas S. Hawkins
Phone: 866-987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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101 W 8th Ave
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The Toledo Hospital/Toledo Children's Hospital ProMedica's Mission is to improve your health and well-being. And...
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111 Michigan Ave NW
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Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Principal Investigator: Rochelle A. Yanofsky
Phone: 866-561-1026
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011

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