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Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739827
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

Approximately 150 cases of cancer per one million per year are considered rare cancers. While all tumors originate from genetic changes, a small percentage of these tumors are familial. Researchers want to study these changes in biological samples from people with rare tumors in order to learn more about how these tumors develop. The information obtained from this study may lead to improved screening, preventive guidelines, and treatments.

Objective:

To better understand rare cancers and hereditary cancer syndromes.

Eligibility:

People who have a rare tumor, a family history of a rare tumor, a hereditary cancer syndrome, or a mutation that leads to rare tumors.

Design:

Participants will be screened with questions about their medical history and/or that of their family members. They will give a saliva sample.

Participants who have a tumor will have their medical records and tests reviewed. They will answer questions about their wellbeing and needs. They may provide a tumor tissue sample.

Participants may also have:

  • Physical exam
  • Clinical photography
  • Blood, urine, saliva, and stool samples taken
  • Consultation with specialists
  • A scan that produces a picture of the body. Either one that uses a small amount of radiation, or one that uses a magnetic field.
  • Genetic testing/genetic counseling.

Participants will be contacted once a year. They will answer updated questions about their medical and family history.

Participants will be asked to contact the study team if there are changes in their tumors.

Participants may be invited to join focus groups for people with the same diagnosis of rare tumors.

Participants may be invited to participate in other NIH protocols.

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RARE TUMOR LIST:

  1. Acinar cell carcinoma of the pancreas
  2. Adamantinoma
  3. Adenosqaumous carcinoma of the pancreas
  4. Adrenocortical carcinoma
  5. Alveolar soft part sarcoma
  6. Anaplastic Thyroid Cancer
  7. Angiosarcoma
  8. Atypical Teratoid Rhabdoid Tumor/MRT
  9. Carcinoid
  10. Carcinoma of Unknown Primary
  11. Chondrosarcoma
  12. Chondromyxoid fibroma
  13. Chordoma
  14. Clear cell renal carcinoma
  15. Clear Cell Sarcoma
  16. Clear cell sarcoma of kidney
  17. Conventional chordoma
  18. Dedifferentiated chordoma
  19. Desmoid
  20. Desmoplastic small round cell tumor
  21. Epithelioid hemangioendothelioma
  22. Esthenioneuroblastoma
  23. Ewing Sarcoma
  24. Fibrolamellar carcinoma
  25. Fusion negative rhabdomyosarcoma
  26. Fusion positive renal cell carcinoma
  27. Fusion positive rhabdomyosarcoma
  28. Gastro-enteropancreatic neuroendocrine tumor
  29. Hepatoblastoma
  30. Hereditary Diffuse Gastric Cancer
  31. Inflammatory myofibroblastic tumor
  32. Kaposiform hemangioendothelioma
  33. Malignant ectomesenchymal tumor
  34. Malignant peripheral nerve sheath tumor
  35. Malignant triton tumor
  36. Medullary thyroid cancer
  37. Mixed acinar adenocarcinoma
  38. Mixed acinar neuroendocrine carcinoma
  39. Myxoid Liposarcoma
  40. Neuroblastoma
  41. Neuroendocrine tumors
  42. NUT midline carcinoma
  43. Osteosarcoma
  44. Pancreas ductal adenocarcinoma with squamous features
  45. Pancreatic acinar cell carcinoma
  46. Papillary renal cell carcinoma
  47. Paraganglioma
  48. Parosteal Osteosarcoma
  49. Periosteal Osteosarcoma
  50. Peripheral nerve sheath tumor
  51. Peripheral primitive neuroectodermal tumor
  52. Pheochromocytoma
  53. Pituitary cancer
  54. Poorly differentiated chordoma
  55. Renal medullary carcinoma
  56. Rhabdomyosarcoma
  57. Round cell Liposarcoma
  58. Schwannoma
  59. Sclerosing Epithelioid Fibrosarcoma
  60. SDH deficient GIST
  61. SMARCB1 deficient tumors
  62. SMARCA4 deficient tumors
  63. Synovial sarcoma
  64. Undifferentiated Sarcoma

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Condition or disease
Malignant Solid Tumors Other Neoplasms Solid Tumors Pediatric Solid Tumor Refractory Solid Tumors Solid Tumor

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History and Biospecimen Acquisition Study for Children and Adults With Rare Solid Tumors
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : March 31, 2028

Group/Cohort
1/Cohort 1
Subjects with a diagnosis of rare tumor (fewer than 15 cases in 100,000 people per year)
2/Cohort 2
Relatives of subjects with a rare tumor who have a germline genetic variant that predispose to a rare solid tumor or a subject who has a germline genetic variant that predispose to a rare solid tumor
3/Cohort 3
Relatives of subjects with a diagnosis of rare tumor that do NOT have known germline genetic variants that predispose to a rare solid tumor.
4/ Cohort 4
Parents/guardians of children with a diagnosis of rare tumor participating in focus groups (if not enrolled in Cohorts 1, 2 or 3)



Primary Outcome Measures :
  1. To comprehensively and longitudinally evaluate the natural history of patients with rare solid tumors or tumor predisposition syndromes, estimating and defining their clinical spectrum (e.g. disease course and survival) [ Time Frame: 10 years ]
    To comprehensively and longitudinally evaluate the natural history of patients with rare solid tumors or tumor predisposition syndromes, estimating and defining their clinical spectrum (e.g. disease course and survival)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary clinical
Criteria
  • INCLUSION CRITERIA:
  • Cohort 1: Participants with a diagnosis of a rare solid tumor (fewer than 15 cases in 100,000 people per year). There are no age restrictions beyond the neonatal period (4 weeks).

OR

-Cohort 2: Participants without a rare tumor who have a germline genetic variant that predisposes to a rare solid tumor

OR

-Cohort 3: Relatives of participants with diagnosis of rare solid tumors who do NOT have a known germline variant that predisposes to a rare solid tumor

OR

  • Cohort 4: Parent/guardian of child participating in a focus group if not already enrolled on the study.
  • Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

None


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): NCT03739827


Contacts
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Contact: Barbara (BJ) Thomas, R.N. (240) 858-3633 barbara.thomas2@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: Mary F Wedekind Malone, D.O. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03739827    
Other Study ID Numbers: 190016
19-C-0016
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: September 23, 2021

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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) ):
Service to the Patients
Knowledge about the Nature of Cancer
Cancer Evaluations
Additional relevant MeSH terms:
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Neoplasms