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| ID | Type | Description | Link |
|---|---|---|---|
| 834664 | Other Identifier | The University of Pennsylvania Institutional Review Board | |
| DAA3-19-65331-1 | Other Identifier | National Institute of Allergy and Infectious Diseases (NIAID) |
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| Name | Class |
|---|---|
| Tata Memorial Hospital | OTHER_GOV |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The investigators propose to prospectively study the difference in treatment (CTRT) completion and toxicities between HIV positive and HIV negative women in India with locally advanced cervical cancer receiving CTRT.
This study will compare chemoradiation completion rates for cervical cancer in two groups, women with HIV and women without HIV. The investigators will also be analyzing tumor tissue for tumor infiltrating lymphocytes which are thought to be involved in disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV Positive | Cervical Cancer Patients with HIV positive |
| |
| HIV Negative | Cervical Cancer Patients with HIV negative |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Standard of Care Chemoradiation for Cervical cancer patients in India. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion Rates of Cancer Treatment | To evaluate and compare the completion rates of cancer treatment in HIV positive cervical cancer patients and HIV negative cervical cancer patients. Treatment adherence is defined as receiving at least 5 cycles of weekly cisplatin chemotherapy and completion of all prescribed radiation (including brachytherapy) and chemotherapy within 8 weeks of treatment initiation. | 2 years |
| Impact of HIV Infection on acute toxicities | To compare the incidence of acute grade ≥3 gastrointestinal, genitourinary and hematological toxicities using CTCAE v4 in patients receiving concurrent cisplatin-based chemo-radiation and brachytherapy for cervical cancer in HIV positive and HIV negative patients. Acute toxicities include any toxicity occurring within 90 days of treatment completion. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor infiltrating lymphocytes (TILs) | To identify and characterize tumor infiltrating lymphocytes (TILs) with reference to numbers and phenotype in tumor biopsies of HIV positive and HIV negative cervical cancer patients in India | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cervical cancer at Tata Memorial Hospital in India.
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| Name | Affiliation | Role |
|---|---|---|
| Surbhi Grover, MD, MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Memorial Hospital | Mumbai | Maharashtra | 400012 | India |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Biopsy specimens collected for Tumor-Infiltrating Lymphocytes (TILs) detection.
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |