Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00588289
Other study ID # 99-068
Secondary ID CA42764
Status Completed
Phase N/A
First received December 24, 2007
Last updated October 8, 2013
Start date September 1999
Est. completion date October 2013

Study information

Verified date October 2013
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This protocol is not an independent research study, but rather a means to aggregate Children's Cancer Group protocols that are closed to patient entry for the purpose of collecting current status information on those patients treated under those protocols.


Description:

Children's Cancer Group clinical trials are conducted to improve understanding of the biology and treatment of childhood cancers. Protocols are developed by expert committees and distributed from the Group Operations Center to the member institutions. Before a protocol can be opened to patient accrual at a CCG institution, the protocol, consent form and any activation amendments are reviewed and approved by the local Institutional Review Board QRB).

Protocols remain open to patient accrual until sufficient evaluable patients have been entered to answer the study questions. During this time, the protocol and any new amendments are reviewed annually by the IRB. When the study has been closed to patient accrual it remains open solely for the purpose of collecting life status and occurrence of adverse events. The IRB must continue its annual review as long as a patient treated on the protocol is alive and follow-up data are being collected. The CCG Long Term Follow-up protocol (CCG-LTF1) is meant to allow continued collective review of all protocols that meet the following criteria: (a) It is closed to patient accrual, (b) all patients have completed treatment, and (c) there are patients who are alive and being followed. The protocols that meet these criteria will be listed as being aggregated under CCG-LTF1 such that an IRB review of CCG-LTF1 will constitute a review of that protocol.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- The patient must have completed anti-cancer treatment according to a CCG protocol, or must have been declared off protocol therapy, but not off study.

- The data to be collected on the patient must include only those data that are documented in the medical record or included on the follow-up forms.

Exclusion Criteria:

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (4)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Children's Oncology Group, National Cancer Institute (NCI), University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Facilitate reporting of adverse events for those who completed treatment; To establish a mechanism for regular annual approval; Decrease the number of active protocols; Develop a framework for future studies of long-term health related outcomes. 2 years No
See also
  Status Clinical Trial Phase
Completed NCT01439152 - Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors. Phase 1
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Active, not recruiting NCT06015009 - Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers N/A
Active, not recruiting NCT03298100 - Risk Scoring Model for Endometrial Cancer
Recruiting NCT05055609 - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors Phase 1
Not yet recruiting NCT04324320 - Psychological Distress in Outpatient Oncological Rehabilitation
Recruiting NCT06222801 - The 1st Tumor CytokinoTherapy Database (TCTD-1)
Recruiting NCT03831633 - Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Phase 4
Completed NCT04914702 - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Recruiting NCT05198570 - Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Recruiting NCT05712174 - A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer Phase 2
Recruiting NCT03832062 - Value of Analysing Under-utilised Leftover Tissue (VauLT)
Completed NCT03988777 - Magnetic Seed Localisation for Nonpalpable Breast Lesions
Recruiting NCT06031233 - Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie Phase 4
Enrolling by invitation NCT04019119 - Digital Intervention for the Modification of Lifestyles (iGame) N/A
Not yet recruiting NCT05926362 - Capillary-Venous Paired Data Collection
Recruiting NCT05686213 - ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial Phase 2
Recruiting NCT05510856 - Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients Phase 4
Completed NCT04180306 - PEWS Implementation in an LMIC Setting N/A
Completed NCT04933604 - LPN in Patients With High-complex Renal Tumors