4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer

NCT05130073 | Completed

• 2 other identifiers: PA19-0088NCI-2021-10964
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Anal Squamous Cell Carcinoma; Stage 0 Anal Cancer AJCC v8; Stage I Anal Cancer AJCC v8; Stage II Anal Cancer AJCC v8; Stage IIA Anal Cancer AJCC v8; Stage IIB Anal Cancer AJCC v8; Stage III Anal Cancer AJCC v8; Stage IIIA Anal Cancer AJCC v8; Stage IIIB Anal Cancer AJCC v8; Stage IIIC Anal Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Follow-Up; Procedure: Positron Emission Tomography

Interventions

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Observational (PET/CT, medical data review, follow-up)

Electronic Health Record Review OTHER

Review of medical records

Observational (PET/CT, medical data review, follow-up)

Follow-Up PROCEDURE

Undergo follow-up

Also known as: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup

Observational (PET/CT, medical data review, follow-up)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Observational (PET/CT, medical data review, follow-up)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with invasive SCCA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson Cancer Center

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Chromatin Immunoprecipitation Sequencing; Follow-Up Studies; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chromatin Immunoprecipitation; Genetic Techniques; Investigative Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Immunologic Techniques; Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Benny Johnson

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: July 31, 2019
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: February 20, 2024

Record last verified: 2023-12

Locations

US (1)