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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.

Must not have

Patients with regional nodal disease or unequivocal metastases

Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to nearby lymph nodes or other parts of my body.

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I do not have any serious illnesses that would stop me from following the study's requirements.

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My tumor is non-cancerous.

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I am scheduled for chemotherapy before surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met