RECRUITING

Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A tissue biopsy is currently the only clinical test or procedure that is able to confirm the initial diagnosis of soft tissue or metastatic sarcoma and evaluate its progress during treatment. However, tissue biopsy collection can be challenging (depending on the location of the tumor), and this procedure poses physical risks to the patient. A tissue biopsy also needs to be recollected at various time points in order to assess if the patient is responding to treatment. In this project, the investigator would like to collect blood samples in addition to the sample of the tumor that will be collected before treatment is started. The investigator would like to analyze both blood and tumor, in hopes of identifying new biomarkers of sarcoma that can help the study doctors better diagnose sarcoma for patients in the future without needing to collect a piece of their tumor. A biomarker is something found in the blood, other body fluids, or tissues that can be used to measure the progress of disease, how a treatment is working, or its likelihood of being successful. In this project, the investigator would like to compare ctDNA from blood to the DNA in the tumor. ctDNA, or circulating tumor DNA, is DNA originating from the tumor that is present in the blood. It can be assessed by taking an additional sample of blood when it will be collected for normal laboratory tests. These biomarkers may also help the study doctors detect how a patient is responding to their treatment or help predict their response to future treatment.

Official Title

Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma

Quick Facts

Study Start:2019-06-18

Study Completion:2025-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03896620

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) prior to any study-specific evaluation. * Diagnosis of soft tissue sarcoma. * ≥ 18 years of age. * Planned biopsy obtained within four weeks after registration. * History and physical within eight weeks prior to registration. * For stage II-III patients, no prior therapy to primary site of sarcoma. * Computerized tomography (CT), positron emission tomography (PET) /CT or MR imaging of the affected primary site obtained in stage II-III or metastatic site in stage IV patients within eight weeks prior to registration. * CT chest or PET /CT acquired to assess distant disease within eight weeks prior to registration for stage II-III patients. * Karnofsky Performance Scale (KPS) 60 or above within four weeks prior to registration. * Documentation of stage within eight weeks prior to registration. * Biopsy of primary or metastatic disease site must be safe, feasible and in concordance with standard of care per the treating physician and/or radiologist. * Life expectancy ≥ 12 weeks.	* Pregnant women. * Patients with a history of metastatic disease from a primary other than sarcoma. * Patients who cannot undergo imaging as part of treatment planning or surveillance.

Inclusion Criteria

Exclusion Criteria

* Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) prior to any study-specific evaluation.
* Diagnosis of soft tissue sarcoma.
* ≥ 18 years of age.
* Planned biopsy obtained within four weeks after registration.
* History and physical within eight weeks prior to registration.
* For stage II-III patients, no prior therapy to primary site of sarcoma.
* Computerized tomography (CT), positron emission tomography (PET) /CT or MR imaging of the affected primary site obtained in stage II-III or metastatic site in stage IV patients within eight weeks prior to registration.
* CT chest or PET /CT acquired to assess distant disease within eight weeks prior to registration for stage II-III patients.
* Karnofsky Performance Scale (KPS) 60 or above within four weeks prior to registration.
* Documentation of stage within eight weeks prior to registration.
* Biopsy of primary or metastatic disease site must be safe, feasible and in concordance with standard of care per the treating physician and/or radiologist.
* Life expectancy ≥ 12 weeks.

* Pregnant women.
* Patients with a history of metastatic disease from a primary other than sarcoma.
* Patients who cannot undergo imaging as part of treatment planning or surveillance.

Contacts and Locations

Study Contact

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

414-805-8900

cccto@mcw.edu

Principal Investigator

Meena Bedi

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Meena Bedi, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-18

Study Completion Date2025-06-01

Study Record Updates

Study Start Date2019-06-18

Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

Sarcoma
ctDNA

Additional Relevant MeSH Terms

Sarcoma