Clinical trial · Observational
4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer
The Role of a 4-point Therapy Response Score With PET/CT Post Definitive Chemoradiation for Anal Squamous Cell Cancer: A Prospective Study
NCT05130073CI-TRIAL-00074139completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Squamous Cell Carcinoma | Anal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage 0 Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Follow-Up | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (PET/CT, medical data review, follow-up)
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Other: Electronic Health Record Review
- Procedure: Follow-Up
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- Through study completion, an average of 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed biopsy proven invasive SCCA (any T, any N) deemed a candidate to undergo standard of care definitive chemoradiation at MD Anderson Cancer Center (MDACC) with curative intent * Age \> 18 years at time of study entry * Ability to provide written informed consent Exclusion Criteria: * Patients unwilling to participate in a PET/CT at baseline and at 3 months post completion of definitive chemoradiation * Patients with an active second primary malignancy requiring chemotherapy or radiation treatment * Stage IV SCCA
References
Publications (0)
Data not yet available
No reference posted for this study.