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Study on examining how biological markers impact treatment outcomes for anal cancer patients undergoing chemo and radiation therapy

An ambispective study on outcomes in anal cancers receiving chemo-radiation with exploratory biomarker analysis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/05/066973
Enrollment
50
Registered
2024-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: C211- Malignant neoplasm of anal canal

Interventions

Control Intervention1: NIL: NIL

Sponsors

Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Histological diagnosis of Squamous cell carcinoma of anal canal. -Patients being treated with curative intent with concurrent chemo- radiotherapy (CTRT) -Age of patient 18 years or older -ECOG status 0 – 2 -Patient consenting for participation in study (Written informed consent for prospective patients, Telephonic informed consent for retrospective patients)

Exclusion criteria

Exclusion criteria: -Unwilling to participate in the study. -Presence of distant metastases. -Medical condition precluding curative intent treatment for the patient. -History of previous treatment for current condition.

Design outcomes

Primary

MeasureTime frame
Expression of various molecular markers (p16, p53, PD-L1 and CAIX) in patients with anal cancer and correlate this with response to chemo-radiotherapy and treatment response rates at 6 months.Timepoint: 1.5 years

Secondary

MeasureTime frame
Baseline expression of these moecular markers and their association with acute treatment toxicities based on RTOG toxicity criteria and disease status at 6 months. Also the prevalence of molecular markers in the study population. and association between presence of these molecular markers, patient and disease characteristics and disease outcomes. Timepoint: 1.5 Years

Countries

India

Contacts

Public ContactDr Lincoln Pujari

Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital

tanaybhadbhade99@gmail.com9370101099

Outcome results

None listed

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