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Study to look for better and cost effective localizing material in patients with breast cancer under going neoadjuvant chemotherapy followed by breast conservation surgery.

Randomized controlled study comparing metallic clip with silicone tube tip for localization of breast cancer after neoadjuvant chemotherapy within patients with breast cancer. A superiority study. - CliCLAB

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031233
Enrollment
206
Registered
2021-02-11
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: O- Medical and Surgical

Interventions

Intervention1: Insertion of tip of silicon tube to localize epicenter of breast cancer in patients undergoing neoadjuvant chemotherapy followed by breast conservation surgery: A silicon tube tip will

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Locally advanced breast cancer patients suitable for breast conservation. 2.Partial response with more than 30% reduction of tumour size in longest diameter after two cycles of neoadjuvant. 3.Any triple negative breast cancer planned for NACT.

Exclusion criteria

Exclusion criteria: 1.Breast tumor with widespread skin involvement. 2.Inflammatory and metastatic breast cancers. 3.Contraindication for Radiotherapy. 4.Patients who denied consent 5.Male breast cancer

Design outcomes

Primary

MeasureTime frame
To compare the volume of tissue resected and margin positivity in silicon tube guided breast conserving surgery versus traditional stainless clip guided breast conserving surgery.Timepoint: Margin negativity will be assessed in the resected specimen of Breast conservative surgery, ie. 6-8 cycles of NACT( 18-24 weeks)

Secondary

MeasureTime frame
To compare the cost effectivenes, surgeons ease of tumor localization during surgery and patients experienceTimepoint: cost of localizing material and surgeons ease of localization during surgery

Countries

India

Contacts

Public ContactMohammed Fawaz

All India Institute of Medical Sciences

drpmishra28@gmail.com9971085243

Outcome results

None listed

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