Detection of Circulating Tumor Cells in Patients With Sarcomas

NCT ID: NCT02983539

Last Updated: 2018-07-02

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

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leiomyosarcoma Pleomorphic Liposarcoma Synovial Sarcoma Liposarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AC Camargo Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Ludmilla Thome Domingos Chinen, PhD

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ludmilla Chinen, PhD

Role: PRINCIPAL_INVESTIGATOR

AC Camargo Cancer Center

Locations

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ACCamargo Cancer Center

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Ludmilla Chinen, PhD

Role: CONTACT

55 11 21895000 ext. 2776

Facility Contacts

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Ludmilla Chinen, PhD

Role: primary

1121895000 ext. 2776

References

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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.

Reference Type BACKGROUND
PMID: 26950035 (View on PubMed)

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.

Reference Type RESULT
PMID: 25258541 (View on PubMed)

Other Identifiers

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ACFrance

Identifier Type: -

Identifier Source: org_study_id

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