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

Protocol Details

Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Blood and Lymph Node Malignancy

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

02-C-0210

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
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.

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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 any 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 cases 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 s macroglobulinemia (WM)

3. Non-Hodgkin s Lymphoma (NHL)

4. Hodgkin disease (HD)

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 diagnosis cannot be verified.

-Referred individuals who decline informed consent.


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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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mary L. McMaster, M.D.
National Cancer Institute (NCI)
BG 9609 MEDICAL CENTER DRIVE RM 6E516
9609 MEDICAL CENTER DR.
ROCKVILLE MD 20850
(240) 276-7248
mm349q@nih.gov

NCI Family Study Referrals
National Cancer Institute (NCI)
Attn: Referral Coordinator
Clinical Genetics Branch
9609 Medical Center Drive, Room 6E504, MSC 9772
Bethesda, MD 20892-9772
(800) 518-8474
ncifamilystudyreferrals@mail.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

Clinical Trials Number:

NCT00039676

--Back to Top--

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

Protocol Details

Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Blood and Lymph Node Malignancy

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

02-C-0210

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
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.

--Back to Top--

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 any 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 cases 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 s macroglobulinemia (WM)

3. Non-Hodgkin s Lymphoma (NHL)

4. Hodgkin disease (HD)

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 diagnosis cannot be verified.

-Referred individuals who decline informed consent.


--Back to Top--

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.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Mary L. McMaster, M.D.
National Cancer Institute (NCI)
BG 9609 MEDICAL CENTER DRIVE RM 6E516
9609 MEDICAL CENTER DR.
ROCKVILLE MD 20850
(240) 276-7248
mm349q@nih.gov

NCI Family Study Referrals
National Cancer Institute (NCI)
Attn: Referral Coordinator
Clinical Genetics Branch
9609 Medical Center Drive, Room 6E504, MSC 9772
Bethesda, MD 20892-9772
(800) 518-8474
ncifamilystudyreferrals@mail.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

Clinical Trials Number:

NCT00039676

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