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:
Participants will have other tests every 6-12 months:
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 |
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Chordoma |
Background:
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.
Objective:
-To characterize the natural history of chordoma, including clinical presentation and patterns of disease progression.
Eligibility:
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 |
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 |
Group/Cohort |
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1/Cohort 1
Subjects with confirmed chordoma
|
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 |
EXCLUSION CRITERIA:
-None
Contact: Barbara (BJ) Thomas, R.N. | (240) 858-3633 | barbara.thomas2@nih.gov |
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 |
Principal Investigator: | Brigitte C Widemann, M.D. | National Cancer Institute (NCI) |
Tracking Information | |||||
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First Submitted Date | April 9, 2019 | ||||
First Posted Date | April 10, 2019 | ||||
Last Update Posted Date | March 1, 2021 | ||||
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 |
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
|
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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:
Participants will have other tests every 6-12 months:
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. |
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Detailed Description |
Background:
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.
Objective: -To characterize the natural history of chordoma, including clinical presentation and patterns of disease progression. Eligibility:
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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
|
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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 |
EXCLUSION CRITERIA: -None |
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Sex/Gender |
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Ages | 2 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03910465 | ||||
Other Study ID Numbers | 190082 19-C-0082 |
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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 |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | February 25, 2021 |