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NCT Number: NCT02402244

Project: Every Child for Younger Patients With Cancer

This study gathers health information for 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.

Recruiting

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Key information

Conditions

Adrenal Gland Pheochromocytoma Bone Marrow Diseases Carcinoma Carcinoma in Situ Central Nervous System Neoplasm Central Nervous System Neoplasms Childhood Immature Teratoma Childhood Kidney Neoplasm Childhood Langerhans Cell Histiocytosis Childhood Mature Teratoma Congenital Mesoblastic Nephroma Desmoid Fibromatosis Desmoid Tumors Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibroma Ganglioneuroma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Lymphatic Diseases Lymphoproliferative Disorder Lymphoproliferative Disorders Male Urogenital Diseases Malignant Neoplasm Malignant Solid Neoplasm Melanocytic Neoplasm Melanoma Myeloproliferative Disorders Myeloproliferative Neoplasm Neoplasm of Uncertain Malignant Potential Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nephroma, Mesoblastic Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Neoplasm Neuroendocrine Tumors Nevi and Melanomas Paraganglioma Pheochromocytoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stromal Neoplasm Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

John Hunter Children's Hospital, Hunter Regional Mail Centre, New South Wales, Australia

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About this study

PRIMARY OBJECTIVES:

I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline deoxyribonucleic acid (DNA); and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions.

IV. To allow permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the patient or their parents (if applicable).

V. For patients enrolled through adult cooperative groups, to develop a well annotated adolescent and young adult (AYA) cancer biorepository and to screen for eligibility for current and future research through the collection of biospecimens (at diagnosis, time of progression and time of recurrence), including tumor and host DNA; and key clinical data, including presentation, diagnostic, staging, and summary treatment information.

OUTLINE: This is an observational study. Patients are assigned to 1 of 2 protocols.

PROJECT: EVERY CHILD PROTOCOL: Patients undergo medical data review to create a Childhood Cancer Registry. Patients also undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).

PROJECT AYA PROTOCOL: Patients undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 one "1" (borderline), 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
  • All neoplastic lesions of the kidney 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
  • Neuroendocrine tumors including pheochromocytoma
  • Melanocytic tumors, except clearly benign nevi
  • Ganglioneuromas
  • 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

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Undergo cytology specimen collection

Other names: Cytologic Sampling

medical chart review

Other

Undergo medical data review

Other names: Chart Review

Primary outcomes

  1. Number of patients who consented to biobanking

    Time frame: Baseline

    The number of patients who agree to be in the Biobanking part of the study and have leftover tumor tissue and some normal blood, bone marrow, or other tissue saved for future research.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
Mar 30, 2015
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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