Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006518
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2000-11-22
Brief Title:
Specimen Collections From Participants With HIV Infection KSHV Infection Viral-Related Pre-malignant Lesions and Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection of Blood Bone Marrow Tumor or Tissue Samples From Patients With HIV Infection KSHV Infection Viral-Related Pre-Malignant Lesions andor Cancer
Status:
RECRUITING
Status Verified Date:
2024-09-26
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
A number of important scientific advances can be made through the study of blood bone marrow tumor or other tissue samples from patients with HIV infection infection with Kaposi s sarcoma associated herpesvirus KSHV infection with other oncogenic viruses or cancer
This protocol provides a mechanism to affect a variety of such studies
OBJECTIVES
-Acquisition of serum circulating cells bone marrow and tumor or normal tissue samples from participants with HIV infection KSHV infection or with cancer
ELIGIBILITY
-Eligibility criteria include age 18 years or older and at least one of the following Exposure risk to HIV KSHV or HPV HIV seropositive KSHV seropositive EBV seropositive HTLV-1 seropositive malignancy Castleman s disease or skin lesions with appearance of Kaposi s sarcoma or cervical or anal intraepithelial lesion
DESIGN
Up to 999 subjects will be enrolled in this study
Blood samples may be collected at the initial visit and at follow-up visits
Other fluidsexcretions may be collected such as urine saliva semen and stool
Tumor samples may be obtained by fine needle aspirate by removal of pleural or peritoneal fluid by skin punch biopsy or by excisional biopsy providing the tumor is accessible with minimal risk to the participants
Specific risks will be described in a separate consent to be obtained at the time of the biopsy
Samples will be studied in the HIV and AIDS Malignancy Branch CCR NCI laboratories in NCI-Frederick or those of collaborating investigators
A number of important scientific advances can be made through the study of blood bone marrow tumor or other tissue samples from patients with HIV infection infection with Kaposi s sarcoma associated herpesvirus KSHV infection with other oncogenic viruses or cancer
This protocol provides a mechanism to affect a variety of such studies
OBJECTIVES
-Acquisition of serum circulating cells bone marrow and tumor or normal tissue samples from participants with HIV infection KSHV infection or with cancer
ELIGIBILITY
-Eligibility criteria include age 18 years or older and at least one of the following Exposure risk to HIV KSHV or HPV HIV seropositive KSHV seropositive EBV seropositive HTLV-1 seropositive malignancy Castleman s disease or skin lesions with appearance of Kaposi s sarcoma or cervical or anal intraepithelial lesion
DESIGN
Up to 999 subjects will be enrolled in this study
Blood samples may be collected at the initial visit and at follow-up visits
Other fluidsexcretions may be collected such as urine saliva semen and stool
Tumor samples may be obtained by fine needle aspirate by removal of pleural or peritoneal fluid by skin punch biopsy or by excisional biopsy providing the tumor is accessible with minimal risk to the participants
Specific risks will be described in a separate consent to be obtained at the time of the biopsy
Samples will be studied in the HIV and AIDS Malignancy Branch CCR NCI laboratories in NCI-Frederick or those of collaborating investigators
Detailed Description:
BACKGROUND
A number of important scientific advances can be made through the study of blood bone marrow tumor or other tissue samples from patients with HIV infection infection with Kaposi s sarcoma associated herpesvirus KSHV infection with other oncogenic viruses or cancer
This protocol provides a mechanism to affect a variety of such studies
OBJECTIVES
-Acquisition of serum circulating cells bone marrow and tumor or normal tissue samples from participants with HIV infection KSHV infection or with cancer
ELIGIBILITY
-Eligibility criteria include age 18 years or older and at least one of the following Exposure risk to HIV KSHV or HPV HIV seropositive KSHV seropositive EBV seropositive HTLV-1 seropositive malignancy Castleman s disease or skin lesions with appearance of Kaposi s sarcoma or cervical or anal intraepithelial lesion
DESIGN
Up to 999 subjects will be enrolled in this study
Blood samples may be collected at the initial visit and at follow-up visits
Other fluidsexcretions may be collected such as urine saliva semen and stool
Tumor samples may be obtained by fine needle aspirate by removal of pleural or peritoneal fluid by skin punch biopsy or by excisional biopsy providing the tumor is accessible with minimal risk to the participants
Specific risks will be described in a separate consent to be obtained at the time of the biopsy
Samples will be studied in the HIV and AIDS Malignancy Branch CCR NCI laboratories in NCI-Frederick or those of collaborating investigators
A number of important scientific advances can be made through the study of blood bone marrow tumor or other tissue samples from patients with HIV infection infection with Kaposi s sarcoma associated herpesvirus KSHV infection with other oncogenic viruses or cancer
This protocol provides a mechanism to affect a variety of such studies
OBJECTIVES
-Acquisition of serum circulating cells bone marrow and tumor or normal tissue samples from participants with HIV infection KSHV infection or with cancer
ELIGIBILITY
-Eligibility criteria include age 18 years or older and at least one of the following Exposure risk to HIV KSHV or HPV HIV seropositive KSHV seropositive EBV seropositive HTLV-1 seropositive malignancy Castleman s disease or skin lesions with appearance of Kaposi s sarcoma or cervical or anal intraepithelial lesion
DESIGN
Up to 999 subjects will be enrolled in this study
Blood samples may be collected at the initial visit and at follow-up visits
Other fluidsexcretions may be collected such as urine saliva semen and stool
Tumor samples may be obtained by fine needle aspirate by removal of pleural or peritoneal fluid by skin punch biopsy or by excisional biopsy providing the tumor is accessible with minimal risk to the participants
Specific risks will be described in a separate consent to be obtained at the time of the biopsy
Samples will be studied in the HIV and AIDS Malignancy Branch CCR NCI laboratories in NCI-Frederick or those of collaborating investigators
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 |
|---|---|---|---|
| 01-C-0038 | None | None | None |