NCT00039676

Brief Summary

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.

Trial Health

73
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,836

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2002

Completed
1 month until next milestone

Study Start

First participant enrolled

July 8, 2002

Completed
Last Updated

May 1, 2026

Status Verified

January 28, 2026

First QC Date

June 6, 2002

Last Update Submit

April 30, 2026

Conditions

Hodgkin DiseaseMixed Lymphoproliferative DiseaseWaldenstrom MacroglobulinemiaChronic Lymphocytic LeukemiaNonHodgkin Lymphoma

Keywords

GeneticsRisk FactorsNatural HistoryLymphomaLeukemiaLymph Node Cancer

Outcome Measures

Primary Outcomes (1)

  • Clinical Spectrum and Natural History

    To define the clinical spectrum and natural history of familial blood and lymph node malignancies and susceptibility states over time.

    Ongoing

Study Arms (1)

Standard

People that have blood or lymph node cancer, or a family history of leukemia or lymphoma.

Eligibility Criteria

Age11 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population with a family history of cancer

You may qualify if:

  • 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:
  • Chronic lymphocytic leukemia (CLL)
  • Waldenstrom macroglobulinemia (WM)
  • Non-Hodgkin lymphoma (NHL)
  • Hodgkin lymphoma (HL)
  • 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.

You may not qualify if:

  • Referred individuals for whom reported diagnoses cannot be verified;
  • Referred individuals who decline informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

NIH National Cancer Institute - Shady Grove

Rockville, Maryland, 20850, United States

Location

Related Publications (3)

  • 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.

    PMID: 26956414BACKGROUND

  • 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.

    PMID: 27365461BACKGROUND

  • 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 beta 2 associated with disease susceptibility. Blood. 2016 Nov 3;128(18):2261-2263. doi: 10.1182/blood-2016-02-697771. Epub 2016 Sep 14. No abstract available.

    PMID: 27629550BACKGROUND

Related Links

MeSH Terms

Conditions

Waldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellHodgkin DiseaseLymphoma, Non-HodgkinLymphomaLeukemia

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Douglas R Stewart, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2002

First Posted

June 7, 2002

Study Start

July 8, 2002

Last Updated

May 1, 2026

Record last verified: 2026-01-28

Locations

US(2)