Children and Adults With Chordoma

NCT03910465 | Recruiting

• 2 other identifiers: 19008219-C-0082
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Chordoma

Keywords

Rare Tumor; Comprehensive Evaluation and Recommendations; Collecting Clinical, Epidemiologic and Biological Data; Natural History

Outcome Measures

Primary Outcomes (1)

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

  Natural history of chordoma, including clinical presentation and patterns of disease progression

  10 years

Study Arms (1)

1/Cohort 1

Subjects with confirmed chordoma.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary clinical

You may qualify if:

• Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written consent document.
• Subjects with radiographically or 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 .

You may not qualify if:

• None

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

• Wedekind MF, Widemann BC, Cote G. Chordoma: Current status, problems, and future directions. Curr Probl Cancer. 2021 Aug;45(4):100771. doi: 10.1016/j.currproblcancer.2021.100771. Epub 2021 Jul 1.

  PMID: 34266694 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Chordoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Mary F Wedekind Malone, D.O.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara J Thomas, R.N.

CONTACT

(240) 858-3633; barbara.thomas2@nih.gov

Mary F Wedekind Malone, D.O.

CONTACT

(240) 858-3765; maryfrances.wedekindmalone@nih.gov

Study Design

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

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 10, 2019
• Study Start: April 16, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2025-05-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)