NCT00001686

Brief Summary

This protocol is designed to evaluate children with cancer who appear to be probable candidates for future protocol entry or have disease manifestations that are of unique scientific importance or educational value.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
482

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
20.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

22.5 years

First QC Date

November 3, 1999

Last Update Submit

September 8, 2020

Conditions

Ewing's SarcomaLeukemiaLymphomaBrain TumorsRhabdomyosarcoma

Keywords

LeukemiaEwing's SarcomaNeuroectodermal TumorsLymphoma, OsteosarcomaBrain Tumors, RhabdomyosarcomaLymphomaNeoplasmSarcoma

Outcome Measures

Primary Outcomes (1)

  • Evaluate children and adults with cancer

    evaluate longitudinally children and adults with cancer, pre-canceroussyndromes or rare diseases referred to the Pediatric Oncology Branch (POB) who present with disease manifestations that lend themselves to clinical evaluation and are of unique scientific importance

    End of treatment

Study Arms (1)

Cohort A

Children and adults with cancer (or a pre-cancer syndrome or rare disease), between the age(s) of 2 years - 40 years, who present with disease manifestations of special interest to POB investigators.

Eligibility Criteria

Age2 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adults with cancer (or a pre-cancer syndrome/rare disease), between the age(s) of 2 years - 40 years, who present with disease manifestations of special interest to POB investigators.

You may qualify if:

  • A POB, CCR investigator decides that it is in the best interest of the patient and the POB, CCR for the patient to receive treatment and follow-up at the NCI/NIH.
  • Children and adults with cancer (or a pre-cancer syndrome or a rare disease), between the age (s) of 2 years - 40 years (the NIH CC is not well equipped to provide optimal care to patients \< 2 years of age). Note: Patients greater than or equal to 18 and less than or equal to 40 years may be evaluated on this protocol if their cancer (or precancer syndrome or rare disease) is of specific interest to the POB, CCR, NCI.
  • Patients with cancer (or a pre-cancer syndrome or rare disease), who present with disease manifestations of special interest to Pediatric Oncology Branch investigators, including but not limited to, lymphoma, brain tumors, Ewing's sarcoma, leukemia, neuroectodermal tumors, osteosarcoma, rhabdomyosarcoma,RAS-related syndromes and inherited immune disorders, amongst others.
  • Patient must weigh greater than or equal to 12 kg (the NIH CC is not well equipped to provide optimal care to patients \< 12 kg)
  • The patient, parent, guardian or their Legally Authorized Representative (LAR) is able and willing to provide informed consent.
  • Patients, and when indicated, parent, guardian or LAR who are deemed sufficiently reliable to return for recommended follow-up visits.

You may not qualify if:

  • Patients younger than 2 years of age.
  • Patients weighing less than or equal to 12 kg.
  • Pregnant women are excluded from enrollment onto this study because the invasive procedures and/or sedation needed to perform these may cause unnecessary harm to the unborn fetus. In the event a woman becomes pregnant while on study, she will not be removed from the study; however, no invasive clinical or research procedures will be done or cancer treatment provided during pregnancy that include unacceptable risk to the patient and/or to the unborn fetus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Sarcoma, EwingLeukemiaLymphomaBrain NeoplasmsRhabdomyosarcomaNeuroectodermal TumorsOsteosarcomaNeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMyosarcomaNeoplasms, Muscle TissueNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve Tissue

Study Officials

  • Brigitte C Widemann, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

March 19, 1998

Primary Completion

September 2, 2020

Study Completion

September 2, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

US(1)