Protocol Details
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Blood and Lymph Node Malignancy
This study is NOT currently recruiting participants.
Summary
Number | 02-C-0210 |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 11 mo
Max Age: N/A |
Referral Letter Required | No |
Population Exclusion(s) | None |
Keywords | Genetics;
Risk Factors;
Natural History;
Lymphoma;
Leukemia;
Natural History |
Recruitment Keyword(s) | Lymph Node Cancer;
Lymphoma;
Leukemia |
Condition(s) | Waldenstrom Macroglobulinemia;
Chronic Lymphocytic Leukemia;
Hodgkin Disease;
NonHodgkin Lymphoma;
Mixed Lymphoproliferative Disease |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Cancer Institute |
Background:
-Individuals may be prone to develop blood or lymph node cancers (leukemia or lymphoma) for a variety of reasons, including genetic predisposition to these cancers, environmental exposures or other medical conditions.
-Studies of people and families at high risk of cancer often lead to clues about their cause that may also be important regarding the sporadic occurrence of these cancers in the general population.
-Identifying genetic or environmental factors that play a role in the development of these diseases may be important in developing prevention trials, screening programs and treatments.
Objectives:
-Describe the cancers and other conditions in families with blood or lymph node cancer.
-Find and describe genes that may cause blood and lymph node cancer, and understand how they work in families.
-Use laboratory methods to try to determine if it is possible to identify who is at highest risk of blood or lymph node cancer.
-Test how genes act with other factors to alter the risk of disease, its severity or its manifestations in families.
Eligibility:
-Individuals of any age with a personal or family history of a blood or lymph node cancer.
-Individuals with a personal or family history of medical conditions or environmental exposures that may predispose to blood or lymph node cancer.
Design:
-Participants complete questionnaires about their personal and family medical history and provide consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with blood or lymph node cancer, tumors, or other related illnesses for whom they are the legally authorized representative.
-Participants donate a sample of blood or cheek cells, or a lock of hair for genetic studies.
-Patients may also be evaluated at the NIH Clinical Center by one or more of the following specialists: cancer doctor or blood specialist, medical geneticist, research nurses or clinical social worker. They may have blood and urine tests and a cheek swab or mouth wash to collect cheek cells. Some patients may also be asked to have x-rays and routine imaging, such as CT scans or ultrasound tests, cell surface markers, skin biopsy, and, with special consents, bone marrow biopsy, MRI or PET scans, apheresis or fluorescein angiography and photography.
Eligibility
INCLUSION CRITERIA:
On referral, persons >= 11 months will be included only because of personal history, and persons >=18 years can also be included because of personal or family history of the parameters listed below:
-A medical history of hematologic/ lymphoproliferative malignancy of an unusual type, pattern, or number or
-Known or suspected factor(s) predisposing to hematologic malignancy, either genetic and/or congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.)
Personal and family medical history must be verified through questionnaires, interviews, and review of pathology slides and medical records. For familial neoplasms, two or more living affected cases among family members are generally required, although in selected instances exceptions may be made, e.g., for WM, one case plus a living 1st degree relative with an autoimmune condition will qualify a family for further investigations.
Disease-specific considerations. Familial aggregation of any hematologic cancer(s) is eligible for study. Disease-specific procedures are outlined in appendices:
1. Chronic lymphocytic leukemia (CLL)
2. Waldenstrom macroglobulinemia (WM)
3. Non-Hodgkin lymphoma (NHL)
4. Hodgkin lymphoma (HL)
5. Mixed/miscellaneous hematologic and lymphoproliferative diseases
Ability of subject or Legally Authorized Representative (LAR) to understand, and the willingness to sign, a written informed consent document.
EXCLUSION CRITERIA:
-Referred individuals for whom reported diagnoses cannot be verified;
-Referred individuals who decline informed consent.
Citations:
Berndt SI, Camp NJ, Skibola CF, Vijai J, Wang Z, Gu J, Nieters A, Kelly RS, Smedby KE, Monnereau A, Cozen W, Cox A, Wang SS, Lan Q, Teras LR, Machado M, Yeager M, Brooks-Wilson AR, Hartge P, Purdue MP, Birmann BM, Vajdic CM, Cocco P, Zhang Y, Giles GG, Zeleniuch-Jacquotte A, Lawrence C, Montalvan R, Burdett L, Hutchinson A, Ye Y, Call TG, Shanafelt TD, Novak AJ, Kay NE, Liebow M, Cunningham JM, Allmer C, Hjalgrim H, Adami HO, Melbye M, Glimelius B, Chang ET, Glenn M, Curtin K, Cannon-Albright LA, Diver WR, Link BK, Weiner GJ, Conde L, Bracci PM, Riby J, Arnett DK, Zhi D, Leach JM, Holly EA, Jackson RD, Tinker LF, Benavente Y, Sala N, Casabonne D, Becker N, Boffetta P, Brennan P, Foretova L, Maynadie M, McKay J, Staines A, Chaffee KG, Achenbach SJ, Vachon CM, Goldin LR, Strom SS, Leis JF, Weinberg JB, Caporaso NE, Norman AD, De Roos AJ, Morton LM, Severson RK, Riboli E, Vineis P, Kaaks R, Masala G, Weiderpass E, Chirlaque MD, Vermeulen RCH, Travis RC, Southey MC, Milne RL, Albanes D, Virtamo J, Weinstein S, Clavel J, Zheng T, Holford TR, Villano DJ, Maria A, Spinelli JJ, Gascoyne RD, Connors JM, Bertrand KA, Giovannucci E, Kraft P, Kricker A, Turner J, Ennas MG, Ferri GM, Miligi L, Liang L, Ma B, Huang J, Crouch S, Park JH, Chatterjee N, North KE, Snowden JA, Wright J, Fraumeni JF, Offit K, Wu X, de Sanjose S, Cerhan JR, Chanock SJ, Rothman N, Slager SL. Meta-analysis of genome-wide association studies discovers multiple loci for chronic lymphocytic leukemia. Nat Commun. 2016 Mar 9;7:10933. doi: 10.1038/ncomms10933. Rotunno M, McMaster ML, Boland J, Bass S, Zhang X, Burdett L, Hicks B, Ravichandran S, Luke BT, Yeager M, Fontaine L, Hyland PL, Goldstein AM; NCI DCEG Cancer Sequencing Working Group; NCI DCEG Cancer Genomics Research Laboratory, Chanock SJ, Caporaso NE, Tucker MA, Goldin LR. Whole exome sequencing in families at high risk for Hodgkin lymphoma: identification of a predisposing mutation in the KDR gene. Haematologica. 2016 Jul;101(7):853-60. doi: 10.3324/haematol.2015.135475. Epub 2016 Jun 13. Goldin LR, McMaster ML, Rotunno M, Herman SE, Jones K, Zhu B, Boland J, Burdett L, Hicks B, Ravichandran S, Luke BT, Yeager M, Fontaine L, Goldstein AM, Chanock SJ, Tucker MA, Wiestner A, Marti G, Caporaso NE. Whole exome sequencing in families with CLL detects a variant in Integrin <= 2 associated with disease susceptibility. Blood. 2016 Nov 3;128(18):2261-2263. Epub 2016 Sep 14.
Contacts:
Clinical Trials Number:
NCT00039676