Unspecified Childhood Solid Tumor, Protocol SpecificNCT00433394
Registration and Informed Consent Study for the Childhood Cancer Research Network
A study testing cancer prevention intervention and educational intervention in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 21 sites in 2 countries.
Trial summary
RATIONALE: Collecting informed consent from parents of children with cancer to register with the Childhood Cancer Research Network may help the study of cancer in the future. PURPOSE: This study is collecting informed consent to register younger patients with cancer into the Childhood Cancer Research Network. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- cancer prevention intervention and educational intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,242 participants
- Where
- 21 sitesin 2 countries
- Study dates
- May 2001to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Child (< 21 years of age) with newly diagnosed cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
Albany Medical Center Hospital
Albany, New York, 12208-3419
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05405
Driscoll Children's Hospital
Corpus Christi, Texas, 78466
Children's Medical Center - Dayton
Dayton, Ohio, 45404-1815
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, 06360-2875
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, 33901
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0232
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 07601
Cancer Research Center of Hawaii
Honolulu, Hawaii, 95813
East Tennessee Children's Hospital
Knoxville, Tennessee, 37916
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, 48910
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, 90801
Children's Hospitals and Clinics of Minneapolis
Minneapolis, Minnesota, 55404
NYU Cancer Institute at New York University Medical Center
New York, New York, 10016
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068-1174
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095
Tod Children's Hospital - Forum Health
Youngstown, Ohio, 44501
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 1Z2
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, H3H 1P3
About this study
Official title: Protocol for Registration and Consent to the Childhood Cancer Research Network - A Limited Institution Pilot
RATIONALE: Collecting informed consent from parents of children with cancer to register with the Childhood Cancer Research Network may help the study of cancer in the future.
PURPOSE: This study is collecting informed consent to register younger patients with cancer into the Childhood Cancer Research Network.
Read the detailed description
OBJECTIVES:
- Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to register their child's name and address with the Childhood Cancer Research Network.
- Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to be contacted in the future for possible participation in non-therapeutic research studies involving the parents and/or child.
- Facilitate the systematic registration of pediatric and adolescent patients diagnosed with cancer into the Childhood Cancer Research Network.
OUTLINE: Consent is obtained from parents (and pediatric patients, where applicable) to register the patient's and parent's names and addresses with the Childhood Cancer Research Network, provide a copy of the pathology report to the Network, and contact parents in the future for possible non-therapeutic research studies involving the parents and/or child.
Information provided will be held in strict confidence.
PROJECTED ACCRUAL: Not specified
- Being tested
- cancer prevention intervention, educational intervention
- Keywords
- unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cancer prevention interventionProcedure or surgery
educational interventionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1: No Consent for personal identification | Experimental | Data to be collected for this stratum include histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries. Receives: Procedure: educational intervention |
| Stratum 2: Consent for personal identification - No Contact | Experimental | Data will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries. No contact for future to ask me to consider taking part in Research Network approved studies Receives: Procedure: cancer prevention intervention; Procedure: educational intervention |
| Stratum 3: Consent for personal identification - Contact | Experimental | Data will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries Someone from the Childhood Cancer Research Network may contact me in the future to ask me to consider taking part in Research Network approved studies Receives: Procedure: cancer prevention intervention; Procedure: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed consent collection to register with the Childhood Cancer Research Network
Informed consent collection for possible participation in future non-therapeutic research studies
Facilitation of systematic registration into the Childhood Cancer Research Network
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startMay 2001
- Primary completionJan 2007
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julie A. Ross, PhD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433394
- Sponsor's protocol ID
- AADM01P1
- Other IDs
- COG-AADM01P1
- Status last verified
- Jun 2013
- First submitted
- 9 Feb 2007
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Registration and Consent to the Childhood Cancer Research Network - A Limited Institution Pilot
- ClinicalTrials.gov ID
- NCT00433394
- Acronym / sponsor ID
- AADM01P1
- Keywords
- unspecified childhood solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,242 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Collecting informed consent from parents of children with cancer to register with the Childhood Cancer Research Network may help the study of cancer in the future.
PURPOSE: This study is collecting informed consent to register younger patients with cancer into the Childhood Cancer Research Network.
Detailed description
OBJECTIVES:
- Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to register their child's name and address with the Childhood Cancer Research Network.
- Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to be contacted in the future for possible participation in non-therapeutic research studies involving the parents and/or child.
- Facilitate the systematic registration of pediatric and adolescent patients diagnosed with cancer into the Childhood Cancer Research Network.
OUTLINE: Consent is obtained from parents (and pediatric patients, where applicable) to register the patient's and parent's names and addresses with the Childhood Cancer Research Network, provide a copy of the pathology report to the Network, and contact parents in the future for possible non-therapeutic research studies involving the parents and/or child.
Information provided will be held in strict confidence.
PROJECTED ACCRUAL: Not specified
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stratum 1: No Consent for personal identification | Experimental | Procedure: educational interventionData to be collected for this stratum include histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries. |
| Stratum 2: Consent for personal identification - No Contact | Experimental | Procedure: cancer prevention intervention, Procedure: educational interventionData will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries. No contact for future to ask me to consider taking part in Research Network approved studies |
| Stratum 3: Consent for personal identification - Contact | Experimental | Procedure: cancer prevention intervention, Procedure: educational interventionData will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries Someone from the Childhood Cancer Research Network may contact me in the future to ask me to consider taking part in Research Network approved studies |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cancer prevention intervention | Procedure or surgery | Stratum 2: Consent for personal identification - No Contact, Stratum 3: Consent for personal identification - Contact |
| educational intervention | Procedure or surgery | Stratum 1: No Consent for personal identification, Stratum 2: Consent for personal identification - No Contact, Stratum 3: Consent for personal identification - Contact |
Primary outcome
Informed consent collection to register with the Childhood Cancer Research Network
Informed consent collection for possible participation in future non-therapeutic research studies
Facilitation of systematic registration into the Childhood Cancer Research Network
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A. Ross, PhD study chair
Masonic Cancer Center, University of Minnesota
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cancer prevention intervention and educational intervention in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed consent collection to register with the Childhood Cancer Research Network. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2013.