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Detection of Circulating Tumor Cells in Patients With Sarcomas (CTCS)

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ClinicalTrials.gov Identifier: NCT02983539
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ludmilla Thome Domingos Chinen, PhD, AC Camargo Cancer Center

Brief Summary:

The sarcomas represent 1% of all cancers in adults, 8% in adolescents and young people, and 10% in children. Even though it is a rare cancer, it contributes to a significant loss of years of life in comparison with other types of cancer, due the fact that it affects children and young people. The diagnosis and treatment are difficult, considering the diversity and rarity of this disease. In addition, on average, more than 50% of patients with high-grade sarcoma present tumor relapse and distant recurrence is considered the main cause of death. The presence of Circulating Tumor Cells (CTCs) in the blood of patients with sarcoma may be an early marker of tumor invasion, because it is known that the CTCs circulate in the blood for months or years before the development of metastases. The CTCs can be used to monitor the response of the tumor to treatment, in order to match time, dose, and type of therapy.

Objectives: collect blood from patients with different types of sarcoma (leiomyosarcoma, synovial sarcoma, pleomorphic sarcoma and liposarcoma) in order to isolate and quantify CTCs. The investigators also have an intention to identify genes of resistance to treatment in these cells.


Condition or disease
Leiomyosarcoma Pleomorphic Liposarcoma Synovial Sarcoma Liposarcoma

Detailed Description:

Methodology: This is a prospective study, to be made by whole blood collection from 40 patients with different types of sarcomas (leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma). The collections will be made in three different moments: before the beginning of the treatment, during and at the end of this (8 mL). Blood samples will be processed and filtered on ISET system for the isolation and quantification of CTCs. Later, it will be performed immunocytochemistry (ICQ) single and/or double staining for protein assessment. The following proteins will be assessed: CD45, MRP1, MRP2 and MRP7.

Expected Results: The investigators hope that this study can show if the CTCs can be used as "liquid biopsy" in patients with leiomyosarcoma, synovium and pleomorphic sarcoma and liposarcoma.


Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Circulating Tumor Cells in Patients With Metastatic Sarcomas
Study Start Date : October 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018





Primary Outcome Measures :
  1. progression free survival [ Time Frame: 6 months ]
    time to first progression until the second one



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with 4 types of metastatic sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma.
Criteria

Inclusion Criteria:

  • 18 years or more;
  • types of sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma.
  • extension of the disease determined by physical examination and imaging;
  • measurable disease by RECIST criteria (Response Evaluation Criteria in Solid Tumors);

Exclusion Criteria:

  • patients who have undergone previous therapy in the last three weeks;
  • patients with a history of other cancer in the past two years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983539


Contacts
Contact: Ludmilla Chinen, PhD 55 11 21895000 ext 2776 ludmilla.chinen@cipe.accamargo.org.br

Locations
Brazil
ACCamargo Cancer Center Recruiting
Sao Paulo, SP, Brazil, 01509900
Contact: Ludmilla Chinen, PhD    1121895000 ext 2776    ludmilla.chinen@accamargo.org.br   
Principal Investigator: Ludmilla Chinen, PhD         
Sponsors and Collaborators
AC Camargo Cancer Center
Investigators
Principal Investigator: Ludmilla Chinen, PhD AC Camargo Cancer Center

Publications of Results:
Other Publications:
Responsible Party: Ludmilla Thome Domingos Chinen, PhD, Researcher, AC Camargo Cancer Center
ClinicalTrials.gov Identifier: NCT02983539     History of Changes
Other Study ID Numbers: ACFrance
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ludmilla Thome Domingos Chinen, PhD, AC Camargo Cancer Center:
sarcomas
immunocytochemistry
circulating tumor cells

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Synovial
Neoplastic Cells, Circulating
Leiomyosarcoma
Liposarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue