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NTP treatment for Breast Cancer

N/A

Waitlist Available

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is scheduled to undergo a lumpectomy

Age ≥18 years at the time of signing study consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

Study Summary

This trial aims to test the safety of using a type of ionized gas called non-thermal plasma on the area where the tumor was removed in breast cancer patients. The main questions it wants to answer

Who is the study for?

This trial is for breast cancer patients who have had their tumor surgically removed. It's designed to find out the safest dose of a new treatment using non-thermal plasma on the area where the tumor was. Participants will receive this treatment once post-surgery.Check my eligibility

What is being tested?

The study is testing a device called Convertible Plasma Jet, which applies non-thermal plasma directly to the site of tumor removal in breast cancer patients. The aim is to determine safe dosage and evaluate both safety and cosmetic outcomes.See study design

What are the potential side effects?

Since this trial aims to establish safety, potential side effects are being studied; they may include skin reactions at the treatment site or other unforeseen responses due to it being an innovative therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a lumpectomy.

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I am 18 years old or older.

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My breast cancer is in an early to advanced stage, but not based on scans.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incremental increase of NTP dose to reach maximum safe dose.

Secondary outcome measures

Number of patients with adverse events linked to the NTP treatment and type of events.

Number of patients with cosmetic alterations linked to the NTP treatment and type of alterations.

Other outcome measures

Evidence of cancer cell death and effects on normal tissue in samples treated with NTP ex vivo or in situ.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NTP treatmentExperimental Treatment1 Intervention

The patients will be treated with NTP intra-operatively.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

367 Previous Clinical Trials

129,687 Total Patients Enrolled

4 Trials studying Breast Cancer

598 Patients Enrolled for Breast Cancer

Ozmosis Research Inc.Industry Sponsor

20 Previous Clinical Trials

4,985 Total Patients Enrolled

Ministère de l'Économie, de l'Innovation et de l'Énergie, Québec, CanadaUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enlist participants for this trial?

"My apologies for the incorrect information. According to clinicaltrials.gov, this particular trial is not currently recruiting patients. It was originally posted on January 1st, 2024 and last updated on January 15th, 2024. However, it's worth noting that there are presently 2617 other active clinical trials actively seeking participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)

2024. "Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06222788.

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