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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02402244




Registration number
NCT02402244
Ethics application status
Date submitted
25/03/2015
Date registered
30/03/2015
Date last updated
16/04/2019

Titles & IDs
Public title
Project: Every Child for Younger Patients With Cancer
Scientific title
The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
Secondary ID [1] 0 0
NCI-2014-02057
Secondary ID [2] 0 0
APEC14B1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Nervous System Neoplasm 0 0
Childhood Immature Teratoma 0 0
Childhood Langerhans Cell Histiocytosis 0 0
Childhood Malignant Neoplasm 0 0
Childhood Mature Teratoma 0 0
Congenital Mesoblastic Nephroma 0 0
Desmoid-Type Fibromatosis 0 0
Lymphoproliferative Disorder 0 0
Myeloproliferative Neoplasm 0 0
Stromal Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Cytology Specimen Collection Procedure
Other interventions - Medical Chart Review

Observational (Project: Every Child) - Patients undergo medical data review to create a Childhood Cancer Registry. Patients also undergo collection of bio-specimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal cells, saliva, cerebrospinal fluid, or urine).


Other interventions: Cytology Specimen Collection Procedure
Undergo cytology specimen collection

Other interventions: Medical Chart Review
Undergo medical data review

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Preservation of clinically annotated, adequately preserved biological specimens for future research efforts - This protocol is primarily a banking study to facilitate the preservation of clinically annotated, adequately preserved biological specimens for future research efforts.
Timepoint [1] 0 0
Baseline

Eligibility
Key inclusion criteria
- Enrollment must occur within 6 months of initial disease presentation OR within 6
months of refractory disease, disease progression, disease recurrence, second or
secondary malignancy, or post-mortem

- Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome,
Registry and Future Contact components of APEC14B1 any time after they reach age of
majority

- Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent
or young adult populations are eligible for enrollment as follows:

- All cancer cases with an International Classification of Diseases for Oncology
(ICD-O) histologic behavior code of two ?2? (carcinoma in situ) or three ?3?
(malignant)

- All neoplastic lesions of the central nervous system regardless of behavior,
i.e., benign, borderline or malignant

- The following other benign/borderline conditions:

- Mesoblastic nephroma

- Teratomas (mature and immature types)

- Myeloproliferative diseases including transient myeloproliferative disease

- Langerhans cell histiocytosis

- Lymphoproliferative diseases

- Desmoid tumors

- Gonadal stromal cell tumors

- Subjects must be =< 25 years of age at time of original diagnosis, except for patients
who are being screened specifically for eligibility onto a COG (or COG participating
National Clinical Trials Network [NCTN]) therapeutic study, for which there is a
higher upper age limit

- All patients or their parents or legally authorized representatives must sign a
written informed consent and agree to participate in at least one component of the
study; parents will be asked to sign a separate consent for their own biospecimen
submission

- If patients or their parents or legally authorized representatives have not
signed the Part A subject consent form at the time of a diagnostic bone marrow
procedure, it is recommended that they initially provide consent for drawing
extra bone marrow using the Consent for Collection of Additional Bone Marrow;
consent using the Part A subject consent form must be provided prior to any other
procedures for eligibility screening or banking under APEC14B1
Minimum age
No limit
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - Hunter Regional Mail Centre
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [5] 0 0
Monash Medical Center-Clayton Campus - Clayton
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [7] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [8] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2310 - Hunter Regional Mail Centre
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
6008 - Perth
Recruitment postcode(s) [8] 0 0
6009 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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Mississippi
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Nebraska
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Washington
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West Virginia
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Wisconsin
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Alberta
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British Columbia
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Manitoba
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Newfoundland and Labrador
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Ontario
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Saskatchewan
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Auckland
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New Zealand
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Christchurch
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Puerto Rico
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Caguas
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Puerto Rico
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San Juan
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Saudi Arabia
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Riyadh

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This research trial studies the Project: Every Child for younger patients with cancer.
Gathering health information over time from younger patients with cancer may help doctors
find better methods of treatment and on-going care.
Trial website
https://clinicaltrials.gov/show/NCT02402244
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Adamson
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02402244