NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Natural History and Biospecimen Acquisition Study for Children and Adults with Rare Solid Tumors

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-C-0016

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 4 wk
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Service to the Patients;
Knowledge about the Nature of Cancer;
Cancer Evaluations;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Malignant Solid Tumors;
Other Neoplasms Solid Tumors;
Pediatric Solid Tumor;
Refractory Solid Tumors;
Solid Tumor

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

****************************************

****************************************

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

****************************************

****************************************

--Back to Top--

Eligibility

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


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Mary F. Wedekind Malone, D.O.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3750
10 CENTER DR
BETHESDA MD 20892
(240) 858-3765
maryfrances.wedekindmalone@nih.gov

Barbara (BJ) Thomas, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 1-3750
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3633
barbara.thomas2@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT03739827

--Back to Top--