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A study on phylloids tumors of breast- a rare tumor of breast, to help with accurate diagnosis and to decide for the best method of removal

A study to validate the accuracy of the AIIMS modification of Paddington score in diagnosing Phyllodes Tumours, followed by a randomized control trial to evaluate the safety and efficacy of 1cm versus 2cm resection margin in Phyllodes Tumours

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029293
Enrollment
88
Registered
2020-11-23
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: D249- Benign neoplasm of unspecified breast

Interventions

Intervention1: ARM 2 - 2cm margin of resection: Diagnosed cases of Phyllodes tumours of the breast will have excision with a 2cm of normal tissue around it, as margin of resection. Control Interventio

Sponsors

Department of Surgical Disciplines
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A)Women over the age of 18 years B)All biopsy proven cases of Phyllodes tumours  C)Biopsy proven cases of fibroepithelial tumours that also fulfill 1 more criteria of the AIIMS Modification of the Paddington Score D)Willing for follow up  E)Able to understand and give informed consent

Exclusion criteria

Exclusion criteria: A)History of carcinoma/any other tumour in the same breast B)Not willing to consent for surgical procedure

Design outcomes

Primary

MeasureTime frame
Achievement of histological free marginsTimepoint: baseline, 1,3,6 month—

Secondary

MeasureTime frame
A)Clinico-radio-pathological correlation of Phyllodes tumour based on application of the AIIMS Modification of the Paddington Score B) Recurrence of tumour during a follow up period of 1 year C) Evaluation of cosmesis D) Patient quality of life Timepoint: Baseline, 1,3,6,12 months—

Countries

India

Contacts

Public ContactDr Vandhana Rajgopal

AIIMS, New Delhi

vandhana.raj.gopal@gmail.com

Outcome results

None listed

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