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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-10964 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PA19-0088 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study determines whether a positron emission tomography (PET)/computed tomography (CT) 4-point scoring system may predict overall survival for anal squamous cell cancer patients. A 4-point scoring system involving imaging scans may help to predict how patients with anal squamous cell cancer respond to chemoradiation therapy.
PRIMARY OBJECTIVE:
I. To determine whether a PET/CT scoring system in invasive biopsy proven anal squamous cell carcinoma (SCCA) to be treated with chemoradiation with curative intent (any T any N) predicts for overall survival (OS).
SECONDARY OBJECTIVES:
I. To determine whether a PET/CT scoring system in invasive biopsy proven SCCA to be treated with definitive chemoradiation with curative intent predicts for progression free survival (PFS).
II. To determine and validate inter-reader reliability. III. To calculate C-index to evaluate the prognostic capacity of PET/CT scores for survival.
IV. To determine the association between pre-treatment PET/CT scores after treatment and OS.
EXPLORATORY OBJECTIVE:
I. To correlate level of standardized uptake value (SUV) pre and post therapy and its correlation with overall survival.
OUTLINE:
Patients undergo PET/CT at baseline and at 3 months post therapy completion. Patients' medical records are received. Patients are followed up for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (PET/CT, medical data review, follow-up) | Patients undergo PET/CT at baseline and at 3 months post therapy completion. Patients' medical records are received. Patients are followed up for 5 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The Kaplan-Meier method will be used. Log rank test will be used to compare OS between positron emission tomography (PET)/computed tomography (CT) negative and positive tumor group. Multivariable Cox proportional hazards models will be fitted to evaluate the association between OS and PET/CT scores, adjusting for the effects of covariates. In addition to positive and negative tumor groups, PET/CT scores of 4 categories will also be analyzed. C-index will be calculated to evaluate the prognostic capacity of PET/CT score with survival outcomes. Additionally, the Cohen kappa coefficient will be calculated to measure inter-reader agreement. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with invasive SCCA
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| Name | Affiliation | Role |
|---|---|---|
| Benny Johnson | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M.D. Anderson Cancer Center | View source |
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| Electronic Health Record Review | Other | Review of medical records |
|
| Follow-Up | Procedure | Undergo follow-up |
|
|
| Positron Emission Tomography | Procedure | Undergo PET/CT |
|
|
| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D000081204 | Chromatin Immunoprecipitation Sequencing |
| D005500 | Follow-Up Studies |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D047369 | Chromatin Immunoprecipitation |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D059014 | High-Throughput Nucleotide Sequencing |
| D017421 | Sequence Analysis |
| D017422 | Sequence Analysis, DNA |
| D047468 | Immunoprecipitation |
| D007158 | Immunologic Techniques |
| D015331 | Cohort Studies |
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
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