Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001560
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Clinical Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers
Status:
COMPLETED
Status Verified Date:
2011-10-31
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:
This protocol presents the rationale 25-year historical review and methods for multidisciplinary low-risk studies of individuals referred to the NCI Viral Epidemiology Branch VEB Referrals are generally for unusual types of cancer or related conditions known or suspected to be related to viruses Kaposis sarcoma in two homosexual men evaluated in 1981 is a classic example These referral cases provide the basis for pilot studies that generate hypotheses the development of protocols for formal investigations of promising leads and help to set priorities for VEB
A VEB investigator who is a Staff Member at the NIH Clinical Center interviews each subject performs a physical examination draws a blood sample and when appropriate for the disease or virus under study obtains other clinically indicated biological specimens such as urine sputum saliva tears semen Pap smear or cervical anal oral or nasal swabs On occasion other relatively non-invasive studies may be indicated Skin testing with conventional licensed antigens for assessment of cellular immunity may be performed and skin lesions may be biopsied or excised Tumor or other tissue biopsies may be obtained when biopsy or surgery is clinically indicated for other reasons Otherwise no surgery is performed and no therapy is administered Clinical referral to other components of NCI NIH or the private sector are made as needed The biological specimens are frozen or otherwise preserved to be batch tested in current assays or future assays that will be developed Such laboratory testing is performed either at VEBs own support laboratory or collaboratively in other NCI NIH or extramural laboratories that have the needed expertise for the disease or virus under study
Occasionally repeated or more long-term evaluation is required More often a single evaluation in the NIH outpatient clinic or either at a collaborating physicians office or other suitable site in the field is sufficient The VEB investigator provides counseling relevant to the virus or disease under study and about the interim study results He or she makes appropriate referral if needed eg to the Genetic Epidemiology Branch for genetic counseling Clinically relevant results and the VEB investigators interpretation of these results are provided in writing to the subjects primary caregiver Confidentially of the information that is obtained is carefully protected The results of the study are summarized for publication in the peer review literature
A VEB investigator who is a Staff Member at the NIH Clinical Center interviews each subject performs a physical examination draws a blood sample and when appropriate for the disease or virus under study obtains other clinically indicated biological specimens such as urine sputum saliva tears semen Pap smear or cervical anal oral or nasal swabs On occasion other relatively non-invasive studies may be indicated Skin testing with conventional licensed antigens for assessment of cellular immunity may be performed and skin lesions may be biopsied or excised Tumor or other tissue biopsies may be obtained when biopsy or surgery is clinically indicated for other reasons Otherwise no surgery is performed and no therapy is administered Clinical referral to other components of NCI NIH or the private sector are made as needed The biological specimens are frozen or otherwise preserved to be batch tested in current assays or future assays that will be developed Such laboratory testing is performed either at VEBs own support laboratory or collaboratively in other NCI NIH or extramural laboratories that have the needed expertise for the disease or virus under study
Occasionally repeated or more long-term evaluation is required More often a single evaluation in the NIH outpatient clinic or either at a collaborating physicians office or other suitable site in the field is sufficient The VEB investigator provides counseling relevant to the virus or disease under study and about the interim study results He or she makes appropriate referral if needed eg to the Genetic Epidemiology Branch for genetic counseling Clinically relevant results and the VEB investigators interpretation of these results are provided in writing to the subjects primary caregiver Confidentially of the information that is obtained is carefully protected The results of the study are summarized for publication in the peer review literature
Detailed Description:
This protocol presents the rationale 25-year historical review and methods for multidisciplinary low-risk studies of individuals referred to the NCI Viral Epidemiology Branch VEB Referrals are generally for unusual types of cancer or related conditions known or suspected to be related to viruses Kaposis sarcoma in two homosexual men evaluated in 1981 is a classic example These referral cases provide the basis for pilot studies that generate hypotheses the development of protocols for formal investigations of promising leads and help to set priorities for VEB
A VEB investigator who is a Staff Member at the NIH Clinical Center interviews each subject performs a physical examination draws a blood sample and when appropriate for the disease or virus under study obtains other clinically indicated biological specimens such as urine sputum saliva tears semen Pap smear or cervical anal oral or nasal swabs On occasion other relatively non-invasive studies may be indicated Skin testing with conventional licensed antigens for assessment of cellular immunity may be performed and skin lesions may be biopsied or excised Tumor or other tissue biopsies may be obtained when biopsy or surgery is clinically indicated for other reasons Otherwise no surgery is performed and no therapy is administered Clinical referral to other components of NCI NIH or the private sector are made as needed The biological specimens are frozen or otherwise preserved to be batch tested in current assays or future assays that will be developed Such laboratory testing is performed either at VEBs own support laboratory or collaboratively in other NCI NIH or extramural laboratories that have the needed expertise for the disease or virus under study
Occasionally repeated or more long-term evaluation is required More often a single evaluation in the NIH outpatient clinic or either at a collaborating physicians office or other suitable site in the field is sufficient The VEB investigator provides counseling relevant to the virus or disease under study and about the interim study results He or she makes appropriate referral if needed eg to the Genetic Epidemiology Branch for genetic counseling Clinically relevant results and the VEB investigators interpretation of these results are provided in writing to the subjects primary caregiver Confidentiality of the information that is obtained is carefully protected The results of the study are summarized for publication in the peer review literature
A VEB investigator who is a Staff Member at the NIH Clinical Center interviews each subject performs a physical examination draws a blood sample and when appropriate for the disease or virus under study obtains other clinically indicated biological specimens such as urine sputum saliva tears semen Pap smear or cervical anal oral or nasal swabs On occasion other relatively non-invasive studies may be indicated Skin testing with conventional licensed antigens for assessment of cellular immunity may be performed and skin lesions may be biopsied or excised Tumor or other tissue biopsies may be obtained when biopsy or surgery is clinically indicated for other reasons Otherwise no surgery is performed and no therapy is administered Clinical referral to other components of NCI NIH or the private sector are made as needed The biological specimens are frozen or otherwise preserved to be batch tested in current assays or future assays that will be developed Such laboratory testing is performed either at VEBs own support laboratory or collaboratively in other NCI NIH or extramural laboratories that have the needed expertise for the disease or virus under study
Occasionally repeated or more long-term evaluation is required More often a single evaluation in the NIH outpatient clinic or either at a collaborating physicians office or other suitable site in the field is sufficient The VEB investigator provides counseling relevant to the virus or disease under study and about the interim study results He or she makes appropriate referral if needed eg to the Genetic Epidemiology Branch for genetic counseling Clinically relevant results and the VEB investigators interpretation of these results are provided in writing to the subjects primary caregiver Confidentiality of the information that is obtained is carefully protected The results of the study are summarized for publication in the peer review literature
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 97-C-0028 | None | None | None |