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Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT03896620
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Meena Bedi, Medical College of Wisconsin

Tracking Information
First Submitted Date March 28, 2019
First Posted Date April 1, 2019
Last Update Posted Date December 4, 2019
Actual Study Start Date June 18, 2019
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2019)
The proportion of patients with detectable ctDNA changes from pretreatment to posttreatment. [ Time Frame: 5 Years ]
This will be tested using one-sample paired difference in proportions (difference pretreatment vs. posttreatment) at the 0.05 level of significance.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03896620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 28, 2019)
  • The correlation of ctDNA presence with overall survival. [ Time Frame: 5 Years ]
    Cox proportional hazards model with a time-varying covariate, indicating presence/absence of detectable ctDNA at different time points will be considered.
  • The correlation of ctDNA presence with progression-free survival. [ Time Frame: 5 Years ]
    Cox proportional hazards model with a time-varying covariate, indicating presence/absence of detectable ctDNA at different time points will be considered.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
Official Title Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
Brief Summary

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.

Detailed Description

In the proposed study, the investigators wish to prospectively collect blood samples from 25 patients with localized soft tissue sarcomas and 25 patients with metastatic sarcoma (schema III) at various time points outlined. The presence/absence, as well as the change of ctDNA in circulation, will then be measured after the therapies administered and correlated with overall survival, progression-free survival and local control.

The risks to the subjects enrolled on this study include the general risks of undergoing the standard procedures, such as blood draws, imaging, radiation therapy, chemotherapy and surgery, which will be discussed prior to the therapies and images each patient undergoes. The risks of the procedures are not risks of the study with exception to blood draws. There is also a risk of loss of confidentiality, but the data will be deidentified once acquired. Thus, this risk is minimal.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
In this project, the investigator will do genetic testing on blood and tumor samples. Whole genome sequencing will be included as part of the genetic testing for this research. Genetic testing will be done because the study doctor would like to identify new biomarkers of sarcoma.
Sampling Method Non-Probability Sample
Study Population Patients with localized, stage II-III or stage IV histologically confirmed soft tissue sarcomas of the extremity, chest wall or retroperitoneal primaries will be eligible for this study. Stage IV patients may have had prior therapy but must obtain a biopsy within registration requirements for study enrollment.
Condition Sarcoma
Intervention
  • Diagnostic Test: Blood Test - Stage 2-3 Sarcomas Preoperative RT

    Blood samples (10 mL each time) will be collected at the following points:

    • Prior to the start of treatment
    • Four weeks after the last chemotherapy cycle
    • Four weeks after the end of radiation therapy
    • Four weeks after surgery
    • Every four months after surgery up until month 24 months after surgery is completed, or until disease progression
  • Diagnostic Test: Blood Test - Stage 2-3 Sarcomas Postoperative RT

    Blood samples (10 mL each time) will be collected at the following points:

    • Prior to the start of treatment
    • Four weeks after surgery
    • Four weeks after the end of radiation therapy
    • Four weeks after your last chemotherapy cycle
    • Every four months after surgery up until month 24 months after surgery is completed, or until disease progression
  • Diagnostic Test: Blood Test - Stage 4 Sarcomas

    Blood samples (10 mL each time) will be collected at the following points:

    • Prior to the start of treatment
    • Every six weeks after initiation of chemotherapy for one year, or until disease progression
  • Diagnostic Test: Biopsy Sample of Tumor
    A biopsy sample from the tumor will be collected before the start of treatment.
Study Groups/Cohorts
  • Stage II-III Sarcomas undergoing preoperative RT
    Interventions:
    • Diagnostic Test: Blood Test - Stage 2-3 Sarcomas Preoperative RT
    • Diagnostic Test: Biopsy Sample of Tumor
  • Stage II-III Sarcomas undergoing postoperative RT
    Interventions:
    • Diagnostic Test: Blood Test - Stage 2-3 Sarcomas Postoperative RT
    • Diagnostic Test: Biopsy Sample of Tumor
  • Stage IV Sarcomas
    Interventions:
    • Diagnostic Test: Blood Test - Stage 4 Sarcomas
    • Diagnostic Test: Biopsy Sample of Tumor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 28, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2024
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion 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.
  • CT, 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.
  • 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.
  • For patients with stage IV sarcoma: clinically appropriate, standard, first or second line systemic therapy is planned.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 cccto@mcw.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03896620
Other Study ID Numbers PRO00034441
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Meena Bedi, Medical College of Wisconsin
Study Sponsor Medical College of Wisconsin
Collaborators Not Provided
Investigators
Principal Investigator: Meena Bedi Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date December 2019