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Children and Adults With Chordoma

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ClinicalTrials.gov Identifier: NCT03910465
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : December 22, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description
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Brief Summary:

Background:

Chordoma is a rare type of bone cancer. It occurs in the skull base or spine. Researchers want to study people with chordoma in different ways. They hope this will help them design better future treatments and supportive care studies for this disease.

Objective:

To learn more about chordoma by looking at its clinical course, how it appears on imagine scans, and how it responds to therapies and treatments.

Eligibility:

People ages 2 and older with chordoma who are enrolled in NCI protocol 19-C-0016

Design:

Participants will be screened with their medical history.

Participants will have a visit to examine their disease. This will include:

  • Physical exam
  • Neurologic exam
  • CT scan and MRI: Participants will lie on a table. The table will slide into a machine. The machine will take pictures of the body.

Participants will have other tests every 6-12 months:

  • Smell test
  • Surveys to assess their emotional, physical, and behavioral well-being and needs
  • Cognitive function tests

Participants or their home doctors will be contacted every 6 12 months. They will be asked to provide information about their disease. This could include test results and imaging evaluations.

Some participants may be asked to come to the clinic for more visits.


Condition or disease
Chordoma

Detailed Description:

Background:

  • Chordomas are a rare tumor with an incidence of 325 new cases per year in the United States. Pediatric chordomas are very rare and comprise only 5% of all chordoma cases.
  • The standard therapy for localized primary or recurrent chordomas is surgical resection. However, complete surgical resection is often not possible due to the location of the

chordoma.

-For chordomas that cannot be surgically resected, treatment options are limited. Currently,

no standard therapy approach exists for recurrent chordomas. In addition, there are no FDA approved medical therapies for chordoma.

  • The natural history of pediatric and adult chordoma is incompletely understood. Patients with chordoma seek expert advice in the management of their care.
  • The NCI has basic and clinical expertise and research interest in chordoma. The planned natural history study as part of the NCI POB Rare Tumor Patient Engagement Network (RTPEN) will allow for comprehensive evaluation and recommendations to these patients while longitudinally collecting clinical, epidemiologic and biological data.

Objective:

-To characterize the natural history of chordoma, including clinical presentation and patterns of disease progression.

Eligibility:

  • Subjects with histologically documented chordoma.
  • Age greater than or equal to 2 years old

Design:

-This protocol is a subprotocol to protocol 19-C-0016: Natural History and Biospecimen

Acquisition Study for Children and Adults with Rare Solid Tumors . After enrollment on the master protocol and undergoing evaluations detailed, patients will be enrolled on this subprotocol specific for chordoma.

-Medical histories will be documented, and patients followed throughout the course of their disease, with particular attention to patterns of disease recurrence and progression, response to therapies, duration of responses and patient reported outcomes. Tumor growth rates will also be calculated throughout the course of the disease.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History Study of Children and Adults With Chordoma
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Chordoma

Groups and Cohorts
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Group/Cohort
1/Cohort 1
Subjects with confirmed chordoma.


Outcome Measures
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Primary Outcome Measures :
  1. To characterize the natural history of chordoma, including clinical presentation and patterns of disease progression [ Time Frame: 10 years ]
    Natural history of chordoma, including clinical presentation and patterns of disease progression


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary clinical
Criteria
  • INCLUSION CRITERIA:
  • Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written consent document.
  • Subjects with histologically documented chordoma
  • Age greater than or equal to 2 years old
  • Subjects must be enrolled into NCI protocol 19-C-0016: Natural History and Biospecimen Acquisition Study for Children and Adults with Rare Solid Tumors .

EXCLUSION CRITERIA:

-None

Contacts and Locations
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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): NCT03910465


Contacts
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Contact: Barbara (BJ) Thomas, R.N. (240) 858-3633 barbara.thomas2@nih.gov
Contact: Brigitte C Widemann, M.D. (240) 760-6203 widemanb@mail.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: Brigitte C Widemann, M.D. National Cancer Institute (NCI)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03910465    
Other Study ID Numbers: 190082
19-C-0082
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: December 22, 2023
Last Verified: December 14, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

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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) ):
Rare Tumor
Comprehensive Evaluation and Recommendations
Collecting Clinical, Epidemiologic and Biological Data
Natural History
Additional relevant MeSH terms:
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Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms