Circulating Tumor DNA in Soft Tissue Sarcoma

NCT ID: NCT03818412

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2025-01-17

Brief Summary

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This research study will collect blood and tumor tissue samples from patients with soft tissue sarcoma to look at circulating tumor deoxyribonucleic acid (DNA). When tumor cells are damaged or die, DNA from the tumor cells are released into the blood stream as the cells break down. This is called circulating tumor DNA. Circulating tumor DNA is an important biomarker that may be used in cancer detection, prediction of treatment response, and disease monitoring.

Detailed Description

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Researchers are continually looking for ways to understand the biology of cancer such as sarcoma, and ways to improve cancer care and patient outcome.

Research has shown that changes in some genes and/or proteins, called biomarkers, may be important indicators for certain cancers and response to treatments. Genes are molecules made up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for the development and functioning of the cells in the body and are passed down from parent to child. RNA is involved with producing proteins in the body. Further research is needed to better understand the changes found in cancer cells and what this means for certain treatments.

Circulating tumor DNA is an important biomarker that may be used in cancer detection, prediction of treatment response and disease monitoring. When tumor cells are damaged or die, DNA from the tumor cells are released into the blood stream as the cells break down. This is called circulating tumor DNA. Researchers are looking for better ways to detect circulating tumor DNA so that it can be studied.

The purpose of this study is to determine how feasible it is to detect circulating tumor DNA in blood samples of soft tissue sarcoma patients and whether there is a connection between circulating tumor DNA and the likelihood of patients' disease coming back after they receive treatment. To do this, blood and tumor tissue samples will be collected from participants and will undergo DNA testing (reading the contents of their DNA, called sequencing). The results of the DNA testing in the blood samples will be compared with the results from DNA testing that will also be done on tumor tissue. The results will also be compared with participant's response to their treatment, recurrence, and/or long term survival.

Conditions

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Soft Tissue Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Soft Tissue Sarcoma

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

Group Type EXPERIMENTAL

Archival tumor tissue collection and blood draws

Intervention Type PROCEDURE

Archival tumor tissue will be collected for testing of circulating tumor DNA. Blood draws will be taken for testing of circulating tumor DNA.

Interventions

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Archival tumor tissue collection and blood draws

Archival tumor tissue will be collected for testing of circulating tumor DNA. Blood draws will be taken for testing of circulating tumor DNA.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients must have histologically confirmed high-risk extremity or retroperitoneal liposarcoma, leiomyosarcoma and undifferentiated pleomorphic sarcoma.
* Patients must have archival tissue from the diagnostic biopsy available.
* Deemed appropriate for preoperative or postoperative radiotherapy and curative surgery following patient assessment by radiation oncologist and surgical oncologist.
* Age 18 years or older.
* Eastern Cooperative Group (ECOG) performance status ≤ 2
* Ability to understand and willing to sign a written informed consent document and comply with study requirements.

Exclusion Criteria

* Patients with benign histology
* Patients with prior malignancy within previous 5 years or concurrent malignancy other than adequately treated basal cell carcinoma of skin or carcinoma in-situ of cervix.
* Patients with planned neo-adjuvant chemotherapy.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Hospital, Canada

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albiruni Razak, M.D.

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Albiruni Razak, M.D.

Role: CONTACT

416-946-2000

Pernille Pedersen, R.N.

Role: CONTACT

416-946-4501 ext. 2502

Facility Contacts

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Albiruni Razak, M.D.

Role: primary

416-946-2000

Limore Arones, R.N.

Role: backup

416-946-4501 ext. 2504

Other Identifiers

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DNA-TSAR

Identifier Type: -

Identifier Source: org_study_id

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