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

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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.

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.

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
1201 Camino de Salud Northeast
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
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
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
(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
(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
(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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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
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
616.391.9000
Principal Investigator: David S. Dickens
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
(860) 545-9000
Principal Investigator: Michael S. Isakoff
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
(601) 984-1000
Principal Investigator: Gail C. Megason
Phone: 601-815-6700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
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
Las Vegas, Nevada 89102
(702) 383-2000
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Wayne L. Furman
Phone: 901-595-4644
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Principal Investigator: Eric J. Lowe
Phone: 757-668-7243
Children's Hospital of The King's Daughters Children
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Principal Investigator: Jeffrey H. Schwartz
Phone: 904-697-3529
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Jill P. Ginsberg
Phone: 215-590-2810
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Peter H. Shaw
Phone: 412-692-5573
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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401 College Street
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
(210) 567-7000
Principal Investigator: Anne-Marie R. Langevin
Phone: 210-567-0653
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7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Methodist Children's Hospital of South Texas Methodist Children
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: William D. Roberts
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Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
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1540 East Hospital Drive
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Asheville, North Carolina 28801
Principal Investigator: Krystal S. Bottom
Phone: 828-213-4150
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Atlanta, Georgia 30322
Principal Investigator: Marla H. Daves
Phone: 404-778-1868
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Eugenia Chang
Phone: 800-845-4624
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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55 Fruit St
Boston, Massachusetts 02114
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Bronx, New York 10467
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Chattanooga, Tennessee 37403
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Chicago, Illinois 60614
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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100 North Academy Avenue
Danville, Pennsylvania 17822
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Meret Henry
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9333 Imperial Highway
Downey, California 90242
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801 Broadway North
Fargo, North Dakota 58122
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Fort Myers, Florida 33908
Principal Investigator: Emad K. Salman
Phone: 239-343-5333
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: George E. Hucks
Phone: 252-744-2391
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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Jacksonville, Florida 32207
Principal Investigator: Scott M. Bradfield
Phone: 904-697-3529
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
Principal Investigator: Ray C. Pais
Phone: 865-541-8266
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Las Vegas, Nevada 89109
Principal Investigator: Jonathan Bernstein
Phone: 702-384-0013
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Las Vegas, Nevada 89144
Principal Investigator: Jonathan Bernstein
Phone: 702-384-0013
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
Principal Investigator: Jonathan Bernstein
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Las Vegas, Nevada 89109
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
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11234 Anderson St
Loma Linda, California 92354
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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259 1st Street
Mineola, New York 11501
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2525 Chicago Ave
Minneapolis, Minnesota 55404
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445 E 69th St
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201 Lyons Ave
Newark, New Jersey 07112
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Principal Investigator: Ramamoorthy Nagasubramanian
Phone: 407-650-7150
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725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
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3601 A St
Philadelphia, Pennsylvania 19134
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2801 N Gantenbein Ave
Portland, Oregon 97227
(503) 276-6500
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San Francisco, California 94158
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Douglas S. Hawkins
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101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-5437
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
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901 45th St
West Palm Beach, Florida 33407
(561) 844-6300
Saint Mary's Hospital Our team of dedicated physicians, nurses and staff offer a broad spectrum...
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Winnipeg, Manitoba
Principal Investigator: Rochelle A. Yanofsky
Phone: 866-561-1026
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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