4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer
NCT ID: NCT05130073
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
41 participants
OBSERVATIONAL
2019-07-31
2023-12-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Computed Tomography
Undergo PET/CT
Electronic Health Record Review
Review of medical records
Follow-Up
Undergo follow-up
Positron Emission Tomography
Undergo PET/CT
Interventions
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Computed Tomography
Undergo PET/CT
Electronic Health Record Review
Review of medical records
Follow-Up
Undergo follow-up
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years at time of study entry
* Ability to provide written informed consent
Exclusion Criteria
* Patients with an active second primary malignancy requiring chemotherapy or radiation treatment
* Stage IV SCCA
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Benny Johnson
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M.D. Anderson Cancer Center
Other Identifiers
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NCI-2021-10964
Identifier Type: REGISTRY
Identifier Source: secondary_id
PA19-0088
Identifier Type: OTHER
Identifier Source: secondary_id
PA19-0088
Identifier Type: -
Identifier Source: org_study_id
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