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Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors

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ClinicalTrials.gov Identifier: NCT03739827
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

Approximately 150 cases of cancer per one million per year are considered rare cancers. While all tumors originate from genetic changes, a small percentage of these tumors are familial. Researchers want to study these changes in biological samples from people with rare tumors in order to learn more about how these tumors develop. The information obtained from this study may lead to improved screening, preventive guidelines, and treatments.

Objective:

To better understand rare cancers and hereditary cancer syndromes.

Eligibility:

People who have a rare tumor, a family history of a rare tumor, a hereditary cancer syndrome, or a mutation that leads to rare tumors.

Design:

Participants will be screened with questions about their medical history and/or that of their family members. They will give a saliva sample.

Participants who have a tumor will have their medical records and tests reviewed. They will answer questions about their wellbeing and needs. They may provide a tumor tissue sample.

Participants may also have:

  • Physical exam
  • Clinical photography
  • Blood, urine, saliva, and stool samples taken
  • Consultation with specialists
  • A scan that produces a picture of the body. Either one that uses a small amount of radiation, or one that uses a magnetic field.
  • Genetic testing/genetic counseling.

Participants will be contacted once a year. They will answer updated questions about their medical and family history.

Participants will be asked to contact the study team if there are changes in their tumors.

Participants may be invited to join focus groups for people with the same diagnosis of rare tumors.

Participants may be invited to participate in other NIH protocols.

...


Condition or disease
Malignant Solid Tumors Other Neoplasms Solid Tumors Pediatric Solid Tumor Refractory Solid Tumors Solid Tumor

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History and Biospecimen Acquisition Study for Children and Adults With Rare Solid Tumors
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Group/Cohort
1/Cohort 1
Subjects with a diagnosis of rare tumor (fewer than 15 cases in 100,000 people per year)
2/Cohort 2
Relatives of subjects with a diagnosis of rare tumor; familial carriers of germline genetic variants that predispose to rare solid tumor and their relatives
3/Cohort 3
Parents/guardians of children with a diagnosis of rare tumor completing PROs and participating in focus groups (if not enrolled in Cohorts 1 or 2)



Primary Outcome Measures :
  1. To comprehensively and longitudinally evaluate the natural history of patients with rare solid tumors or tumor predisposition syndromes, estimating and defining their clinical spectrum (e.g. disease course and survival) [ Time Frame: 10 years ]
    To comprehensively and longitudinally evaluate the natural history of patients with rare solid tumors or tumor predisposition syndromes, estimating and defining their clinical spectrum (e.g. disease course and survival)



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary clinical
Criteria
  • INCLUSION CRITERIA:
  • Patients with a diagnosis of a rare solid tumor (fewer than 15 cases in 100,000 people per year). Patients with central nervous system tumors will not be included.

OR

- Relatives of patients with diagnosis of rare solid tumors

OR

  • Familial carriers of germline genetic variants that predispose to rare solid tumor and their relatives.
  • Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739827


Contacts
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Contact: BJ Thomas, R.N. (240) 858-3633 barbara.thomas2@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jaydira Del Rivero, M.D. National Cancer Institute (NCI)

Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03739827     History of Changes
Other Study ID Numbers: 190016
19-C-0016
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 7, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Service to the Patients
Knowledge about the Nature of Cancer
Cancer Evaluations

Additional relevant MeSH terms:
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Neoplasms