Detection of Circulating Tumor Cells in Patients With Sarcomas

NCT02983539 | Unknown DMC

• 1 other identifier: ACFrance
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Leiomyosarcoma; Pleomorphic Liposarcoma; Synovial Sarcoma; Liposarcoma

Keywords

sarcomas; immunocytochemistry; circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• progression free survival

  time to first progression until the second one

  6 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with 4 types of metastatic sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma.

You may qualify if:

• 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);

You may not qualify if:

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

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

ACCamargo Cancer Center

São Paulo, São Paulo, 01509900, Brazil

RECRUITING

Related Publications (2)

• Abdallah EA, Fanelli MF, Souza E Silva V, Machado Netto MC, Gasparini Junior JL, Araujo DV, Ocea LM, Buim ME, Tariki MS, Alves Vda S, Piana de Andrade V, Dettino AL, Abdon Lopes de Mello C, Chinen LT. MRP1 expression in CTCs confers resistance to irinotecan-based chemotherapy in metastatic colorectal cancer. Int J Cancer. 2016 Aug 15;139(4):890-8. doi: 10.1002/ijc.30082. Epub 2016 Apr 28.

  PMID: 26950035 BACKGROUND

• Chinen LT, Mello CA, Abdallah EA, Ocea LM, Buim ME, Breve NM, Gasparini JL Junior, Fanelli MF, Paterlini-Brechot P. Isolation, detection, and immunomorphological characterization of circulating tumor cells (CTCs) from patients with different types of sarcoma using isolation by size of tumor cells: a window on sarcoma-cell invasion. Onco Targets Ther. 2014 Sep 16;7:1609-17. doi: 10.2147/OTT.S62349. eCollection 2014.

  PMID: 25258541 RESULT

MeSH Terms

Conditions

Leiomyosarcoma; Liposarcoma; Sarcoma, Synovial; Sarcoma; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Adipose Tissue; Neoplasms, Connective Tissue; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ludmilla Chinen, PhD

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludmilla Chinen, PhD

CONTACT

55 11 21895000; ludmilla.chinen@cipe.accamargo.org.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: December 6, 2016
• Study Start: October 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)