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Nuclear and cytological abnormalities in scrap cytology in patients with pre and early malignant lesions or oral cavity and oropharynx

Cytomorphological features of presence and number of AgNOR avid regions and micronuclear score compared to CK-8 immunoreactive controls in premalignant and early malignant lesions of oral cavity and oropharynx

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022577
Enrollment
160
Registered
2019-12-31
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: D10- Benign neoplasm of mouth and pharynx Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 3: D498- Neoplasm of unspecified behavior of other specified sites

Interventions

Intervention1: Biopsy procedure and histopathological grading â?? Cytological preparation and evaluation : Biopsy procedure and histopathological grading Incisional biopsies will be taken from the

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of premalignant and early malignant oral and oropharyngeal lesions

Exclusion criteria

Exclusion criteria: Patients with known mutation diagnosed tumour syndromes of pre confirmed familial cancer syndromes will be excluded as their molecular progression is already established. Patients not consenting for the study will also be excluded.

Design outcomes

Primary

MeasureTime frame
We expect to find some differential expression of nuclear and micronuclear features such as shape and pattern of nucleus, nuclear staining features, presence and number of AgNOR avid regions and presence, CK-8 immuno-reactivity and number of micronucleus scores in various stages of premalignant and early malignant oral and oropharyngeal lesions which can be further analysed for studying its clinical implications.Timepoint: 0 to 6 months 1 Sample collection 2 Procurement of stains antibodies and detection kit 7 to 18 months 1 Standardization of the staining and IHC protocol 2 Prospective case analysis by staining and IHC 19 to 24 months Compilation of data and submission along with knowledge outcome in terms of a paper

Secondary

MeasureTime frame
A cyto morphological score with a cut off value for malignant changesTimepoint: at 24 months during final analysis

Countries

India

Contacts

Public ContactDr Darwin

AIIMS, Jodhpur

sourabhlipi@gmail.com8360843906

Outcome results

None listed

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