ChordomaNCT03910465
Children and Adults With Chordoma
An observational study of Chordoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Chordoma
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary clinical
Who may be able to join
- 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 >= 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".
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: Natural History Study of Children and Adults With Chordoma
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.
Read more
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.
...
Read the 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 radiographically or 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, participants will be enrolled on this subprotocol specific for chordoma.
- Medical histories will be documented, and participants 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.
- Conditions
- Chordoma
- Keywords
- Rare Tumor, Comprehensive Evaluation and Recommendations, Collecting Clinical, Epidemiologic and Biological Data, Natural History
- Medical subject headings
- Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Cohort 1 | Subjects with confirmed chordoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start16 Apr 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChordomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary F Wedekind Malone, D.O., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910465
- Sponsor's protocol ID
- 190082
- Other IDs
- 19-C-0082
- Status last verified
- 13 Oct 2026
- First submitted
- 9 Apr 2019
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
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.
PubMed 34266694
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Study of Children and Adults With Chordoma
- ClinicalTrials.gov ID
- NCT03910465
- Acronym / sponsor ID
- 190082
- Conditions
- Chordoma
- Keywords
- Rare Tumor, Comprehensive Evaluation and Recommendations, Collecting Clinical, Epidemiologic and Biological Data, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 radiographically or 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, participants will be enrolled on this subprotocol specific for chordoma.
- Medical histories will be documented, and participants 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Cohort 1 | – | –Subjects with confirmed chordoma. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary clinical
Key inclusion criteria (4 listed)
- 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 >= 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".
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 34266694Wedekind 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary F Wedekind Malone, D.O. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chordoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara J Thomas, R.N. ((240) 858-3633, barbara.thomas2@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the natural history of chordoma, including clinical presentation and patterns of disease progression (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.