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

Correlation of clinico-pathological characteristics of Oesophageal Squamous Cell Carcinoma with its positivity for Human Papilloma Virus : A Prospective Observational Exploratory Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/06/034151
Enrollment
50
Registered
2021-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C15- Malignant neoplasm of esophagus

Interventions

Intervention1: NIL: NIL

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactNeha Mishra

AIIMS Rishikesh

drksrajkumar@gmail.com9940155250

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026