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Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer Clinical research trials and Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer. Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer  Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer
For Condition: Hereditary Neoplastic Syndrome,Neoplasm
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a clinical, epidemiologic, genetic, and laboratory study of individuals and families at high risk of cancer and selected tumors to investigate the genetic susceptibility and environmental exposures which may alter cancer risk. Families with multiple members who have an unusual pattern or number of cancers or tumors are evaluated clinically. This evaluation is specific for the type of cancer or tumor predominant in the family in order to determine the affection status of each individual for genetic epidemiologic studies. Genetic and environmental risk factor information specific for the tumor type is obtained. Individuals with, or at high risk of, cancer because of their personal, familial, or environmental histories are identified by healthcare worker referral or by personal inquiry. Relevant etiologic risk factor information is documented through review of pathology specimens and medical, vital, and genealogical records. Selected individuals and family members are asked to complete questionnaires and to undergo clinical evaluations specific for the tumor of interest. They are also asked to donate biologic specimens to be used in the search for cancer etiology and mechanisms of carcinogenesis. No therapy beyond counseling and education for cancer prevention, risk reduction, and early detection will be given. Genetic testing for tumor susceptibility gene(s) mutations and risk notification will be offered to study participants for whom a specific mutation predictive of disease has been identified in his/her family. This testing will only be offered when reasonable individual cancer risk estimates can be delivered, and only to those participants who choose to know their individual genetic status after appropriate education and counseling. The testing will be conducted exclusively in Clinical Laboratory Improvement Amendments (CLIA)-licensed laboratories. Genetic testing and risk notification are entirely optional and do not affect participation in other aspects of the protocol. A separate consent procedure and consent form will be used for genetic testing and risk notification related to these specific genes. Once enrolled, study participants are monitored prospectively for the development of outcomes of interest, typically by means of periodic mail or telephone contact. In selected instances, subjects may return to the Clinical Center periodically for study-specific follow-up examinations. Although we do not offer specific anti-cancer therapy as part of this protocol, we provide assistance to insure that study participants who require treatment for tumor-related problems that develop during the course of the study are referred to appropriate healthcare providers. We remain available to study participants and their healthcare providers for advice and consultation related to the management of familial cancer/tumor predisposition.
Details: This is a clinical, epidemiologic, genetic, and laboratory study of individuals and families at high risk of cancer and selected tumors to investigate the genetic susceptibility and environmental exposures which may alter cancer risk. Families with multiple members who have an unusual pattern or number of cancers or tumors are evaluated clinically. This evaluation is specific for the type of cancer or tumor predominant in the family in order to determine the affection status of each individual for genetic epidemiologic studies. Genetic and environmental risk factor information specific for the tumor type is obtained. Individuals with, or at high risk of, cancer because of their personal, familial, or environmental histories are identified by healthcare worker referral or by personal inquiry. Relevant etiologic risk factor information is documented through review of pathology specimens and medical, vital, and genealogical records. Selected individuals and family members are asked to complete questionnaires and to undergo clinical evaluations specific for the tumor of interest. They are also asked to donate biologic specimens to be used in the search for cancer etiology and mechanisms of carcinogenesis. No therapy beyond counseling and education for cancer prevention, risk reduction, and early detection will be given. Genetic testing for tumor susceptibility gene(s) mutations and risk notification will be offered to study participants for whom a specific mutation predictive of disease has been identified in his/her family. This testing will only be offered when reasonable individual cancer risk estimates can be delivered, and only to those participants who choose to know their individual genetic status after appropriate education and counseling. The testing will be conducted exclusively in Clinical Laboratory Improvement Amendments (CLIA)-licensed laboratories. Genetic testing and risk notification are entirely optional and do not affect participation in other aspects of the protocol. A separate consent procedure and consent form will be used for genetic testing and risk notification related to these specific genes. Once enrolled, study participants are monitored prospectively for the development of outcomes of interest, typically by means of periodic mail or telephone contact. In selected instances, subjects may return to the Clinical Center periodically for study-specific follow-up examinations. Although we do not offer specific anti-cancer therapy as part of this protocol, we provide assistance to insure that study participants who require treatment for tumor-related problems that develop during the course of the study are referred to appropriate healthcare providers. We remain available to study participants and their healthcare providers for advice and consultation related to the management of familial cancer/tumor predisposition.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: On referral, persons of any age will be considered for the inclusion in the study because of either: a family or personal history of neoplasia of an unusual type, pattern, or number; OR, known or suspected factor(s) predisposing to neoplasia, 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.). For familial neoplasms, must have two or more living affected cases among family members are required. The type of familial tumors that we are currently actively accruing include: Familial Cancers: bladder, brain, chordoma, lung, nevoid basal cell carcinoma syndrome (NBCC). Familial Benign Neoplasms: meningiomas, neurofibromatosis 2 (bilateral acoustic neurofibromatosis). EXCLUSION CRITERIA: Referred individuals and families for whom reported diagnoses cannot be verified. Inability to provide informed consent. Eligible for familial melanoma, lymphoproliferative, breast-ovarian cancer, or testicular cancer protocols. Pregnant women are ineligible for the parts of the protocol that involve exposure to ionizing radiation or magnetic fields
Total Enrollment: 7500
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Stephanie Steinbart 8005188474
Additional Information:
Study ID Numbers: 780039; 78-C-0039
Study Start Date: March 20, 1978
Record last reviewed: June 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001163
Other Neoplasm Studies:
1. Clinical Evaluation of a Laser Heated, Fiberoptic-Coupled Radiation Dose Verification System
2. Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
3. A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms
4. Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients with Advanced Cancer
5. Process and Outcomes of Pain Management
Related Studies:
Other Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer
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