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Sponsored by: |
Children's Cancer and Leukaemia Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00436774 |
RATIONALE: Treatment for pediatric extracranial germ cell tumors may cause side effects and secondary cancers later in life. A study that evaluates patients after receiving combination chemotherapy or surgery may help doctors understand the side effects and secondary cancers that occur later in life.
PURPOSE: This study is looking at treatment outcome and quality of life in patients with pediatric extracranial germ cell tumors previously treated on clinical trial CCLG-GC-1979-01 or CCLG-GC-1989-01.
Condition | Intervention |
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Cancer-Related Problem/Condition Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Ovarian Cancer |
Procedure: assessment of therapy complications Procedure: quality-of-life assessment |
Study Type: | Observational |
Official Title: | Cross-Sectional Evaluation of Outcome Following Extra-Cranial Germ Cell Tumors Treated According to UKCCSG GC 7901 (GC I) and GC 8901 (GC II) Protocols |
Estimated Enrollment: | 60 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a cohort, multicenter study.
Patients complete questionnaires about ototoxicity, bladder and bowel dysfunction, and sexual function and fertility as appropriate. They also complete a health-related quality-of-life questionnaire over 20 minutes.
Treating physicians complete a lower-limb and neurologic dysfunction questionnaire. Data from myelodysplasia, second malignancy, ototoxicity, nephrotoxicity, and pulmonary toxicity assessments are collected from the patient's treating physician.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 5 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Previously enrolled in 1 of the following United Kingdom Children's Cancer Study Group (UKCCSG) clinical trials for treatment of extracranial germ cell tumors:
CCLG-GC-1979-01
Attending or in contact with a UKCCSG center
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Ireland | |
Our Lady's Hospital for Sick Children Crumlin | Recruiting |
Dublin, Ireland, 12 | |
Contact: Fin Breatnach, MD, FRCPE 353-1-409-6659 fin.breatnach@olhsc.ie | |
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Amos Burke, MD 44-1223-348-151 | |
Birmingham Children's Hospital | Recruiting |
Birmingham, England, United Kingdom, B4 6NH | |
Contact: Martin W. English, MD 44-121-333-8412 martin.english@bch.nhs.uk | |
Children's Hospital - Sheffield | Recruiting |
Sheffield, England, United Kingdom, S10 2TH | |
Contact: Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk | |
Great Ormond Street Hospital for Children | Recruiting |
London, England, United Kingdom, WC1N 3JH | |
Contact: Gill Levitt, MD 44-20-7405-9200 ext. 0073 | |
Oxford Radcliffe Hospital | Recruiting |
Oxford, England, United Kingdom, 0X3 9DU | |
Contact: Kate Wheeler, MD 44-186-522-1066 | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Adam Glaser, MD 44-113-206-4984 adam.glaser@leedsth.nhs.uk | |
Leicester Royal Infirmary | Recruiting |
Leicester, England, United Kingdom, LE1 5WW | |
Contact: Mabrouk Madi, MD 44-116-258-5959 | |
Middlesex Hospital | Recruiting |
London, England, United Kingdom, W1T 3AA | |
Contact: Ananth Shankar, MD 44-20-7380-9300 ext. 9950 | |
Institute of Child Health at University of Bristol | Recruiting |
Bristol, England, United Kingdom, BS2 8AE | |
Contact: Pamela Kearns, MD 44-117-342-8260 | |
Queen's Medical Centre | Recruiting |
Nottingham, England, United Kingdom, NG7 2UH | |
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH 44-115-924-9924 ext. 43394 martin.hewitt@nuh.nhs.uk | |
Royal Liverpool Children's Hospital, Alder Hey | Recruiting |
Liverpool, England, United Kingdom, L12 2AP | |
Contact: Heather P. McDowell, MD 44-151-293-3679 | |
Royal Manchester Children's Hospital | Recruiting |
Manchester, England, United Kingdom, M27 4HA | |
Contact: Bernadette Brennan, MD 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Mary Taj, MD 44-20-8642-6011 ext. 1307 | |
Sir James Spence Institute of Child Health | Recruiting |
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
Contact: Juliet Hale, MD 44-191-282-4101 j.p.hale@ncl.ac.uk | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942 | |
United Kingdom, Northern Ireland | |
Royal Belfast Hospital for Sick Children | Recruiting |
Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
Contact: Anthony McCarthy, MD 44-289-063-3631 anthonymcarthy@royalhospital.n.i.nhs.uk | |
United Kingdom, Scotland | |
Royal Aberdeen Children's Hospital | Recruiting |
Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
Contact: Veronica Neefjes 44-1224-550-217 | |
Royal Hospital for Sick Children | Recruiting |
Glasgow, Scotland, United Kingdom, G3 8SJ | |
Contact: Milind D. Ronghe, MD 44-141-201-9309 | |
Royal Hospital for Sick Children | Recruiting |
Edinburgh, Scotland, United Kingdom, EH9 1LF | |
Contact: W. Hamish Wallace, MD 44-131-536-0426 | |
United Kingdom, Wales | |
Childrens Hospital for Wales | Recruiting |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 heidi.traunecker@cardiffandvale.wales.nhs.uk |
Study Chair: | Adam Glaser, MD | Leeds Cancer Centre at St. James's University Hospital |
Study ID Numbers: | CDR0000531140, CCLG-GC-2006-06, EU-20642 |
Study First Received: | February 15, 2007 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00436774 |
Health Authority: | Unspecified |
long-term effects secondary to cancer therapy in children neurotoxicity gastrointestinal complications pulmonary complications sexual dysfunction and infertility sexuality and reproductive issues |
urinary complications childhood extragonadal germ cell tumor childhood malignant ovarian germ cell tumor childhood malignant testicular germ cell tumor childhood teratoma |
Ovarian cancer Infertility Ovarian Neoplasms Neurotoxicity Syndromes Gonadal Disorders Neurotoxicity syndromes Genital Neoplasms, Female Quality of Life Endocrine System Diseases Urogenital Neoplasms |
Testicular Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Testicular cancer Endocrinopathy Teratoma Extragonadal Germ Cell Tumor Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Adnexal Diseases |