Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039676
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2002-06-06
Brief Title:
Clinical Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Blood and Lymph Node Malignancy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Background
Persons may be prone to develop hematologic or lymphoproliferative cancer for a variety of reasons including inherited predisposition of benign premalignant or malignant conditions environmental exposures shared by family members previous tumors or preneoplastic conditions immune deficiency or stochastic processes
Investigations of individuals and families at high risk of cancer often lead to etiologic clues that may be important in the sporadic counterparts of these cancers in the general population
Identification of etiologically important genetic factors could inform chemoprevention trials screening programs and treatment of hematologic and lymphoproliferative cancers
Objectives
To evaluate and define the clinical spectrum and natural history of disease in syndromes predisposing to hematologic cancer
To evaluate potential precursor states of malignancy in families at risk
To quantify the risks of specific tumors in family members and define syndromic constellations
To identify map characterize clone and determine function of tumor susceptibility genes
To validate and test associations of biomarkers with risk
To identify genetic determinants environmental factors and gene-environmental interactions conferring cancer risk in individuals and families
To identify differences and similarities between the familial and sporadic condition
To educate and counsel study participants about their risk of hematologic malignancy including prevention recommendations and early detection activities when known
To develop syndrome-specific educational materials for medical professionals and high-risk family members
Eligibility
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 hematologiclymphoproliferative malignancy of an unusual type pattern or number or
there are known or suspected factors predisposing to hematologic malignancy either genetic or congenital factors environmental exposure or unusual demographic features
For familial neoplasms two or more living affected cases among family members are generally required
Design
This is a prospective study Families are studied long-term using a cohort approach
The study design and evaluation vary by the specific type of familial neoplasm being studied
The overall approach to eligible families includes defining affection status characterization of disease localization of genetic loci identification of genes evaluation of phenotypegenotype correlations estimation of risk of the disease associated with carrier
status and identification of other risk factors that modify penetrance genetic environmental and host factors
Persons may be prone to develop hematologic or lymphoproliferative cancer for a variety of reasons including inherited predisposition of benign premalignant or malignant conditions environmental exposures shared by family members previous tumors or preneoplastic conditions immune deficiency or stochastic processes
Investigations of individuals and families at high risk of cancer often lead to etiologic clues that may be important in the sporadic counterparts of these cancers in the general population
Identification of etiologically important genetic factors could inform chemoprevention trials screening programs and treatment of hematologic and lymphoproliferative cancers
Objectives
To evaluate and define the clinical spectrum and natural history of disease in syndromes predisposing to hematologic cancer
To evaluate potential precursor states of malignancy in families at risk
To quantify the risks of specific tumors in family members and define syndromic constellations
To identify map characterize clone and determine function of tumor susceptibility genes
To validate and test associations of biomarkers with risk
To identify genetic determinants environmental factors and gene-environmental interactions conferring cancer risk in individuals and families
To identify differences and similarities between the familial and sporadic condition
To educate and counsel study participants about their risk of hematologic malignancy including prevention recommendations and early detection activities when known
To develop syndrome-specific educational materials for medical professionals and high-risk family members
Eligibility
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 hematologiclymphoproliferative malignancy of an unusual type pattern or number or
there are known or suspected factors predisposing to hematologic malignancy either genetic or congenital factors environmental exposure or unusual demographic features
For familial neoplasms two or more living affected cases among family members are generally required
Design
This is a prospective study Families are studied long-term using a cohort approach
The study design and evaluation vary by the specific type of familial neoplasm being studied
The overall approach to eligible families includes defining affection status characterization of disease localization of genetic loci identification of genes evaluation of phenotypegenotype correlations estimation of risk of the disease associated with carrier
status and identification of other risk factors that modify penetrance genetic environmental and host factors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-0210 | None | None | None |