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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000531140 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20642 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| assessment of therapy complications | Procedure | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin | ||
| Nephrotoxicity as measured by serum magnesium, calcium, and creatinine and glomerular filtration rate in patients previously treated with cisplatin or carboplatin | ||
| Myelodysplasia and second malignancies in patients previously treated with etoposide | ||
| Pulmonary toxicity as measured by lung function test and respiratory symptom questionnaire in patients previously treated with bleomycin | ||
| Bladder and bowel dysfunction, sexual function, and fertility as measured by patient-completed questionnaires and lower limb and neurological dysfunction as measured by clinician-completed questionnaires in patients with pelvic or sacrococcygeal tumors | ||
| Quality of life (QOL) as measured by pediatric cancer quality-of-life inventory or Short Form 36 questionnaires |
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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-1989-01
CCLG-GC-1979-01
At least 5 years since completion of therapy in these clinical trials
Attending or in contact with a UKCCSG center
No recurrent or progressive disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Glaser, MD | Leeds Cancer Centre at St. James's University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospital for Sick Children Crumlin | Recruiting | Dublin | 12 | Ireland |
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| Institute of Child Health at University of Bristol | Recruiting | Bristol | England | BS2 8AE | United Kingdom |
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| Addenbrooke's Hospital | Recruiting | Cambridge | England | CB2 2QQ | United Kingdom |
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| Leeds Cancer Centre at St. James's University Hospital | Recruiting | Leeds | England | LS9 7TF | United Kingdom |
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| Great Ormond Street Hospital for Children | Recruiting | London | England | WC1N 3JH | United Kingdom |
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| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Recruiting | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
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| Children's Hospital - Sheffield | Recruiting | Sheffield | England | S10 2TH | United Kingdom |
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| Southampton General Hospital | Recruiting | Southampton | England | SO16 6YD | United Kingdom |
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| Royal Marsden - Surrey | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
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| Royal Aberdeen Children's Hospital | Recruiting | Aberdeen | Scotland | AB25 2ZG | United Kingdom |
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| Royal Hospital for Sick Children | Recruiting | Edinburgh | Scotland | EH9 1LF | United Kingdom |
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| Royal Hospital for Sick Children | Recruiting | Glasgow | Scotland | G3 8SJ | United Kingdom |
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| Childrens Hospital for Wales | Recruiting | Cardiff | Wales | CF14 4XW | United Kingdom |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D020258 | Neurotoxicity Syndromes |
| D010051 | Ovarian Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| C562841 | Ovarian Germ Cell Cancer |
| D013736 | Testicular Neoplasms |
| D013724 | Teratoma |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D013733 | Testicular Diseases |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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