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Due to the scarcity of data on prognostic and predictive influence on CCA, epidemiological studies evaluating these factors need to be developed in patients with CCA. Therefore, the investigators want to evaluate the profile of patients in the real world and from various parts of the world, describing prognostic factors such as CD4 dosage, time of HIV infection, evaluation of viral load, diagnosis of AIDS, geographic region of diagnosis and treatment, clinical staging, medications concomitant with QRT (risk of drug interactions), comorbidities (possible impact on dose-intensity), use of HAART, time of use of HAART, radiotherapy modality (conventional 3D vs Modulated Beam Intensity [IMRT], response to Nigro vs CTII regimens, as well as comparing clinical outcomes with patients without HIV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With HIV Infection | Patients with CCA with HIV infection, | ||
| Without HIV Infection | Patients with CCA without HIV infection, |
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| Measure | Description | Time Frame |
|---|---|---|
| Median disease-free survival | Defined as time from Day 1 from initiation of treatment (or definition of exclusive supportive care) to tumor death or recurrence. Disease-free survival at 3 years after initiation of treatment: proportion of patients free of local or metastatic disease at 3 years after treatment termination according to imaging tests (chest, abdomen and pelvis scans) and clinical examination of anal inspection | 3 years |
| Complete clinical response | Absence of neoplasia on magnetic resonance imaging (preferred) or computed tomography of the pelvis and on clinical examination of anal inspection 6 months after the end of QRT or RT isolated | 6 months |
| Overall survival | Defined as the date from the D1 of treatment (or exclusive supportive care) to death from any cause; living patients at the time of the analysis will be censored. | From first date of treatment to date of death from any cause, assessed up to 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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Potentially eligible patients will be screened through the administrative lists of participating centres. Based on convenience and viability, we estimate to accumulate 300 patients with CCA with and without HIV infection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viviane Horn de Melo | Contact | +55 51 3384 5334 | viviane.melo@lacogcancerresearch.org | |
| Laura Voelcker | Contact | +55 51 3384 5334 | laura.voelcker@lacogcancerresearch.org |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Riechelmann | Brazilian Group of Gastrointestinal Tumors | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.C. Camargo Cancer Center | Recruiting | São Paulo | 01509-001 | Brazil |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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We will also note whether tumor tissue is available from pre-treatment biopsy at the participating center to plan future translational studies.
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |