Lymphoma Clinical Trial
Official title:
Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma
Verified date | January 2024 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 203 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 29 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Canada | Children's Hospital | London | Ontario |
Canada | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec |
Canada | The Montreal Children's Hospital of the MUHC | Montreal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) | Quebec | |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
United States | Albany Medical Center | Albany | New York |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Mission Hospital | Asheville | North Carolina |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | Saint Luke's Cancer Institute - Boise | Boise | Idaho |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | T C Thompson Children's Hospital | Chattanooga | Tennessee |
United States | Lurie Children's Hospital-Chicago | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Rainbow Babies and Childrens Hospital | Cleveland | Ohio |
United States | Columbia Regional | Columbia | Missouri |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Blank Children's Hospital | Des Moines | Iowa |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Kaiser Permanente Downey Medical Center | Downey | California |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Sanford Broadway Medical Center | Fargo | North Dakota |
United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | BI-LO Charities Children's Cancer Center | Greenville | South Carolina |
United States | East Carolina University | Greenville | North Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida |
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
United States | East Tennessee Childrens Hospital | Knoxville | Tennessee |
United States | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada |
United States | Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada |
United States | Summerlin Hospital Medical Center | Las Vegas | Nevada |
United States | Sunrise Hospital and Medical Center | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | Saint Barnabas Medical Center | Livingston | New Jersey |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Miller Children's and Women's Hospital Long Beach | Long Beach | California |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Saint Jude Children's Research Hospital | Memphis | Tennessee |
United States | Miami Cancer Institute | Miami | Florida |
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | NYU Winthrop Hospital | Mineola | New York |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | The Children's Hospital at TriStar Centennial | Nashville | Tennessee |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Ochsner Medical Center Jefferson | New Orleans | Louisiana |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | NYP/Weill Cornell Medical Center | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Children's Hospital of The King's Daughters | Norfolk | Virginia |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children's Hospital of Orange County | Orange | California |
United States | Nemours Children's Hospital | Orlando | Florida |
United States | Lucile Packard Children's Hospital Stanford University | Palo Alto | California |
United States | Nemours Children's Clinic - Pensacola | Pensacola | Florida |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Legacy Emanuel Children's Hospital | Portland | Oregon |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Rady Children's Hospital - San Diego | San Diego | California |
United States | UCSF Medical Center-Mission Bay | San Francisco | California |
United States | UCSF Medical Center-Parnassus | San Francisco | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | State University of New York Upstate Medical University | Syracuse | New York |
United States | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida |
United States | Tampa General Hospital | Tampa | Florida |
United States | ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio |
United States | New York Medical College | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Saint Mary's Hospital | West Palm Beach | Florida |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls | 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. | Up to 12 months | |
Primary | Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline | Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation. | Baseline up to end of chemotherapy | |
Primary | Degree of recovery of AMH, FSH, and E2 in the post-therapy phase | Generalized estimating equation (GEE) will be used to model the change as a function of time. | Up to 12 months | |
Secondary | Rate of AOF | Describe the number of patients with AOF as measured at 12 months by an FSH > 40 divided by the total population. | Up to 12 months | |
Secondary | Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms | Describe the number of samples collected. | At enrollment (or diagnosis) and Day 5 post enrollment |
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