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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 : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date April 9, 2019
First Posted Date April 10, 2019
Last Update Posted Date May 4, 2020
Actual Study Start Date April 16, 2019
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Children and Adults With Chordoma
Official Title Natural History Study of Children and Adults With Chordoma
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population primary clinical
Condition Chordoma
Intervention Not Provided
Study Groups/Cohorts 1/Cohort 1
Subjects with confirmed chordoma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 9, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2029
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Barbara (BJ) Thomas, R.N. (240) 858-3633 barbara.thomas2@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03910465
Other Study ID Numbers 190082
19-C-0082
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Principal Investigator: Brigitte C Widemann, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 29, 2020