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Circulating DNA Analysis for Soft Tissue Sarcoma

N/A

Recruiting

Led By Albiruni Razak, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Patients must have histologically confirmed high-risk extremity or retroperitoneal liposarcoma, leiomyosarcoma and undifferentiated pleomorphic sarcoma.

Age 18 years or older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will collect blood and tumor tissue samples to study circulating tumor DNA, which may be useful for cancer detection, predicting treatment response, and disease monitoring.

Who is the study for?

This trial is for adults over 18 with high-risk soft tissue sarcoma who are suitable for surgery and radiotherapy. They must have a performance status indicating they can care for themselves, have tumor tissue from a biopsy, and be able to consent to the study. Those with other recent cancers, metastases, serious illnesses affecting compliance or planned chemotherapy are excluded.Check my eligibility

What is being tested?

The study is collecting blood samples and archival tumor tissues from patients to analyze circulating tumor DNA (ctDNA). This ctDNA may help in detecting cancer, predicting how well treatments might work, and monitoring the disease's progression during treatment.See study design

What are the potential side effects?

Since this trial involves only collection of blood samples and archival tumor tissues without any direct interventions like drugs or therapies being tested on participants, there are no side effects associated with typical clinical trials.

Eligibility Criteria

Inclusion Criteria

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

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I have a confirmed diagnosis of a high-risk sarcoma in my limbs or abdomen.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification

Secondary outcome measures

Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence

Trial Design

1Treatment groups

Experimental Treatment

Group I: Soft Tissue SarcomaExperimental Treatment1 Intervention

A sample of archival tumor tissue will be collected. Blood samples (about 20-30 mL or 1-2 tablespoons each sample) will be taken: Prior to planned radiation treatment 2-4 weeks after cancer surgery Every 12 weeks after surgery for up to 2 years

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,475 Previous Clinical Trials

485,050 Total Patients Enrolled

Mount Sinai Hospital, CanadaOTHER

196 Previous Clinical Trials

67,568 Total Patients Enrolled

The Hospital for Sick ChildrenOTHER

690 Previous Clinical Trials

6,945,438 Total Patients Enrolled

Media Library

Archival tumor tissue collection and blood draws Clinical Trial Eligibility Overview. Trial Name: NCT03818412 — N/A

Soft Tissue Sarcoma Research Study Groups: Soft Tissue Sarcoma

Soft Tissue Sarcoma Clinical Trial 2023: Archival tumor tissue collection and blood draws Highlights & Side Effects. Trial Name: NCT03818412 — N/A

Archival tumor tissue collection and blood draws 2023 Treatment Timeline for Medical Study. Trial Name: NCT03818412 — N/A

Frequently Asked Questions

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

What is the maximum capacity of patients for this research project?

"Affirmative. The information on clinicaltrials.gov reaffirms that this medical trial is actively seeking patients, commencing from January 17th 2019 and most recently updated April 11 2021. 40 participants are expected to be recruited over the course of one site."

Answered by AI

Are there unfilled slots available for the trial's participants?

"Affirmative. The information posted on clinicaltrials.gov confirms that this trial is presently seeking participants, which were initially advertised on the 17th of January 2019 and have been updated as recently as the 11th April 2021. 40 patients must be sourced from one medical centre for participation in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Circulating Tumor DNA in Soft Tissue Sarcoma

2019. "Circulating Tumor DNA in Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03818412.

All > Soft Tissue Sarcoma