Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas

Sponsor
Children's Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01793233
Collaborator
National Cancer Institute (NCI) (NIH)
205
Enrollment
107
Locations
114.5
Anticipated Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

  2. Describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.

  3. Evaluate degree of change of AMH/FSH/E2 from baseline to end of therapy in patients.

  4. Evaluate degree of recovery of AMH/FSH/E2 from end of therapy to 12 months off therapy.

SECONDARY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
205 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma
Actual Study Start Date :
Jun 17, 2013
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Ancillary-Correlative (menstrual diary, biomarker analysis)

Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collections at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Outcome Measures

Primary Outcome Measures

  1. Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls [Up to 12 months]

    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.

  2. Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline [Baseline up to end of chemotherapy]

    Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.

  3. Degree of recovery of AMH, FSH, and E2 in the post-therapy phase [Up to 12 months]

    Generalized estimating equation (GEE) will be used to model the change as a function of time.

Secondary Outcome Measures

  1. Rate of AOF [Up to 12 months]

    Describe the number of patients with AOF as measured at 12 months by an FSH > 40 divided by the total population.

  2. Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms [At enrollment (or diagnosis) and Day 5 post enrollment]

    Describe the number of samples collected.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 29 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Children's Hospital of AlabamaBirminghamAlabamaUnited States35233
2Arkansas Children's HospitalLittle RockArkansasUnited States72202-3591
3Kaiser Permanente Downey Medical CenterDowneyCaliforniaUnited States90242
4City of Hope Comprehensive Cancer CenterDuarteCaliforniaUnited States91010
5Loma Linda University Medical CenterLoma LindaCaliforniaUnited States92354
6Miller Children's and Women's Hospital Long BeachLong BeachCaliforniaUnited States90806
7Children's Hospital of Orange CountyOrangeCaliforniaUnited States92868
8Lucile Packard Children's Hospital Stanford UniversityPalo AltoCaliforniaUnited States94304
9Rady Children's Hospital - San DiegoSan DiegoCaliforniaUnited States92123
10UCSF Medical Center-ParnassusSan FranciscoCaliforniaUnited States94143
11UCSF Medical Center-Mission BaySan FranciscoCaliforniaUnited States94158
12Connecticut Children's Medical CenterHartfordConnecticutUnited States06106
13Alfred I duPont Hospital for ChildrenWilmingtonDelawareUnited States19803
14Children's National Medical CenterWashingtonDistrict of ColumbiaUnited States20010
15Golisano Children's Hospital of Southwest FloridaFort MyersFloridaUnited States33908
16Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywoodFloridaUnited States33021
17Nemours Children's Clinic-JacksonvilleJacksonvilleFloridaUnited States32207
18Miami Cancer InstituteMiamiFloridaUnited States33176
19Nemours Children's HospitalOrlandoFloridaUnited States32827
20Nemours Children's Clinic - PensacolaPensacolaFloridaUnited States32504
21Johns Hopkins All Children's HospitalSaint PetersburgFloridaUnited States33701
22Tampa General HospitalTampaFloridaUnited States33606
23Saint Joseph's Hospital/Children's Hospital-TampaTampaFloridaUnited States33607
24Saint Mary's HospitalWest Palm BeachFloridaUnited States33407
25Children's Healthcare of Atlanta - EglestonAtlantaGeorgiaUnited States30322
26University of Hawaii Cancer CenterHonoluluHawaiiUnited States96813
27Kapiolani Medical Center for Women and ChildrenHonoluluHawaiiUnited States96826
28Saint Luke's Cancer Institute - BoiseBoiseIdahoUnited States83712
29Lurie Children's Hospital-ChicagoChicagoIllinoisUnited States60611
30University of Chicago Comprehensive Cancer CenterChicagoIllinoisUnited States60637
31Riley Hospital for ChildrenIndianapolisIndianaUnited States46202
32Blank Children's HospitalDes MoinesIowaUnited States50309
33University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowaUnited States52242
34University of Kentucky/Markey Cancer CenterLexingtonKentuckyUnited States40536
35Ochsner Medical Center JeffersonNew OrleansLouisianaUnited States70121
36Sinai Hospital of BaltimoreBaltimoreMarylandUnited States21215
37Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMarylandUnited States21287
38Massachusetts General Hospital Cancer CenterBostonMassachusettsUnited States02114
39Dana-Farber Cancer InstituteBostonMassachusettsUnited States02215
40C S Mott Children's HospitalAnn ArborMichiganUnited States48109
41Wayne State University/Karmanos Cancer InstituteDetroitMichiganUnited States48201
42Helen DeVos Children's Hospital at Spectrum HealthGrand RapidsMichiganUnited States49503
43Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolisMinnesotaUnited States55404
44University of Mississippi Medical CenterJacksonMississippiUnited States39216
45Columbia RegionalColumbiaMissouriUnited States65201
46Children's Mercy Hospitals and ClinicsKansas CityMissouriUnited States64108
47University Medical Center of Southern NevadaLas VegasNevadaUnited States89102
48Sunrise Hospital and Medical CenterLas VegasNevadaUnited States89109
49Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas VegasNevadaUnited States89135
50Summerlin Hospital Medical CenterLas VegasNevadaUnited States89144
51Nevada Cancer Research Foundation NCORPLas VegasNevadaUnited States89169
52Hackensack University Medical CenterHackensackNew JerseyUnited States07601
53Saint Barnabas Medical CenterLivingstonNew JerseyUnited States07039
54Morristown Medical CenterMorristownNew JerseyUnited States07960
55Newark Beth Israel Medical CenterNewarkNew JerseyUnited States07112
56University of New Mexico Cancer CenterAlbuquerqueNew MexicoUnited States87102
57Albany Medical CenterAlbanyNew YorkUnited States12208
58Montefiore Medical Center - Moses CampusBronxNew YorkUnited States10467
59Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263
60NYU Winthrop HospitalMineolaNew YorkUnited States11501
61NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew YorkUnited States10032
62NYP/Weill Cornell Medical CenterNew YorkNew YorkUnited States10065
63Stony Brook University Medical CenterStony BrookNew YorkUnited States11794
64State University of New York Upstate Medical UniversitySyracuseNew YorkUnited States13210
65New York Medical CollegeValhallaNew YorkUnited States10595
66Mission HospitalAshevilleNorth CarolinaUnited States28801
67East Carolina UniversityGreenvilleNorth CarolinaUnited States27834
68Wake Forest University Health SciencesWinston-SalemNorth CarolinaUnited States27157
69Sanford Broadway Medical CenterFargoNorth DakotaUnited States58122
70Rainbow Babies and Childrens HospitalClevelandOhioUnited States44106
71Cleveland Clinic FoundationClevelandOhioUnited States44195
72Nationwide Children's HospitalColumbusOhioUnited States43205
73ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledoOhioUnited States43606
74University of Oklahoma Health Sciences CenterOklahoma CityOklahomaUnited States73104
75Legacy Emanuel Children's HospitalPortlandOregonUnited States97227
76Oregon Health and Science UniversityPortlandOregonUnited States97239
77Geisinger Medical CenterDanvillePennsylvaniaUnited States17822
78Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States19104
79Saint Christopher's Hospital for ChildrenPhiladelphiaPennsylvaniaUnited States19134
80Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvaniaUnited States15224
81BI-LO Charities Children's Cancer CenterGreenvilleSouth CarolinaUnited States29605
82T C Thompson Children's HospitalChattanoogaTennesseeUnited States37403
83East Tennessee Childrens HospitalKnoxvilleTennesseeUnited States37916
84Saint Jude Children's Research HospitalMemphisTennesseeUnited States38105
85The Children's Hospital at TriStar CentennialNashvilleTennesseeUnited States37203
86Vanderbilt University/Ingram Cancer CenterNashvilleTennesseeUnited States37232
87Dell Children's Medical Center of Central TexasAustinTexasUnited States78723
88UT Southwestern/Simmons Cancer Center-DallasDallasTexasUnited States75390
89Cook Children's Medical CenterFort WorthTexasUnited States76104
90Methodist Children's Hospital of South TexasSan AntonioTexasUnited States78229
91University of Texas Health Science Center at San AntonioSan AntonioTexasUnited States78229
92Children's Hospital of The King's DaughtersNorfolkVirginiaUnited States23507
93Virginia Commonwealth University/Massey Cancer CenterRichmondVirginiaUnited States23298
94Seattle Children's HospitalSeattleWashingtonUnited States98105
95Providence Sacred Heart Medical Center and Children's HospitalSpokaneWashingtonUnited States99204
96University of Wisconsin Hospital and ClinicsMadisonWisconsinUnited States53792
97Children's Hospital of WisconsinMilwaukeeWisconsinUnited States53226
98CancerCare ManitobaWinnipegManitobaCanadaR3E 0V9
99IWK Health CentreHalifaxNova ScotiaCanadaB3K 6R8
100McMaster Children's Hospital at Hamilton Health SciencesHamiltonOntarioCanadaL8N 3Z5
101Kingston Health Sciences CentreKingstonOntarioCanadaK7L 2V7
102Children's HospitalLondonOntarioCanadaN6A 5W9
103Children's Hospital of Eastern OntarioOttawaOntarioCanadaK1H 8L1
104Hospital for Sick ChildrenTorontoOntarioCanadaM5G 1X8
105The Montreal Children's Hospital of the MUHCMontrealQuebecCanadaH3H 1P3
106Centre Hospitalier Universitaire Sainte-JustineMontrealQuebecCanadaH3T 1C5
107Centre Hospitalier Universitaire de QuebecQuebecCanadaG1V 4G2

Sponsors and Collaborators

  • Children's Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jennifer M Levine, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01793233
Other Study ID Numbers:
  • ALTE11C1
  • NCI-2013-00069
  • ALTE11C1
  • COG-ALTE11C1
  • ALTE11C1
  • U10CA095861
  • UG1CA189955
First Posted:
Feb 15, 2013
Last Update Posted:
Sep 5, 2021
Last Verified:
Dec 1, 2020

Study Results

No Results Posted as of Sep 5, 2021