Role of Human Papilloma Virus in Oesophageal Squamous Cell Carcinoma : An Observational Study

Not Applicable

• Conditions: Health Condition 1: C15- Malignant neoplasm of esophagus

• Registration Number: CTRI/2021/06/034151
• Lead Sponsor: AIIMS Rishikesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients with histologically confirmed diagnosis of oesophageal squamous cell carcinoma aged 18 years and above

Exclusion Criteria

1.Oesophageal Cancer other than Squamous Cell Histology.

2.Patients in whom adequate biopsy specimen cannot be taken due to technical reasons or anatomical inaccessibility.

3.Patients with significant comorbidities which preclude full participation in the study

4.Patients who have received Radiotherapy or Chemotherapy in the past due to any other cause.

1.Oesophageal Cancer other than Squamous Cell Histology.

2.Patients in whom adequate biopsy specimen cannot be taken due to technical reasons or anatomical inaccessibility.

3.Patients with significant comorbidities which preclude full participation in the study

4.Patients who have received Radiotherapy or Chemotherapy in the past due to any other cause.

1.Oesophageal Cancer other than Squamous Cell Histology.

2.Patients in whom adequate biopsy specimen cannot be taken due to technical reasons or anatomical inaccessibility.

3.Patients with significant comorbidities which preclude full participation in the study

4.Patients who have received Radiotherapy or Chemotherapy in the past due to any other cause.

5.Recurrent Cancers or concurrent other malignancies

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage at Presentation: Clinical stage at presentation will be collected as per TNM AJCC 8th Edition (cTNM) and compared between the HPV positive and negative groups. Further, Tumour length, location (sub site), grade, nodal distribution and grade of dysphagia will also be compared.Timepoint: At initial Presentation

Secondary Outcome Measures

Name	Time	Method
1.Prevalence of HPV in oesophageal SCC assessed by PCR at initial presentation <br/ ><br>2.Response to Chemotherapy ± radiotherapy (neoadjuvant, definitive and palliative) will be assessed by the following measures: <br/ ><br>a.Radiological Assessment: RECIST 1.1 on CECT scan <br/ ><br>b.Pathological Assessment (for patients who undergo surgery post neoadjuvant treatment): Tumour Regression Score (AJCC/CAP) <br/ ><br>Timepoint: 1. At initial presentation <br/ ><br>2. At 6 weeks post treatment completion(Post Surgery or post Definitive or palliative CTRT)