LeiomyosarcomaCTCSNCT02983539
Detection of Circulating Tumor Cells in Patients With Sarcomas
An observational study of Leiomyosarcoma and Pleomorphic Liposarcoma, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Leiomyosarcoma, Pleomorphic Liposarcoma, Synovial Sarcoma
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with 4 types of metastatic sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma.
Who may be able to join
- 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);
Who cannot join
- patients who have undergone previous therapy in the last three weeks;
- patients with a history of other cancer in the past two years.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
ACCamargo Cancer Center
São Paulo, São Paulo, 01509900
Ludmilla Chinen, PhD, 1121895000 ext. 2776, ludmilla.chinen@accamargo.org.br
Ludmilla Chinen, PhD
About this study
Official title: Detection of Circulating Tumor Cells in Patients With Metastatic Sarcomas
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.
Read the 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.
- Conditions
- Leiomyosarcoma, Pleomorphic Liposarcoma, Synovial Sarcoma, Liposarcoma
- Keywords
- sarcomas, immunocytochemistry, circulating tumor cells
- Medical subject headings
- Leiomyosarcoma, Liposarcoma, Sarcoma, Synovial, Sarcoma, Neoplastic Cells, Circulating
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
time to first progression until the second one
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeiomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ludmilla Thome Domingos Chinen, PhD, AC Camargo Cancer Center
- Investigators
- Ludmilla Chinen, PhD, Principal investigator, AC Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983539
- Sponsor's protocol ID
- ACFrance
- Acronym
- CTCS
- Status last verified
- Jun 2018
- First submitted
- 27 Oct 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26950035Chinen 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.
PubMed 25258541
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Circulating Tumor Cells in Patients With Metastatic Sarcomas
- ClinicalTrials.gov ID
- NCT02983539
- Acronym / sponsor ID
- CTCS / ACFrance
- Conditions
- Leiomyosarcoma, Pleomorphic Liposarcoma, Synovial Sarcoma, Liposarcoma
- Keywords
- sarcomas, immunocytochemistry, circulating tumor cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with 4 types of metastatic sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma.
Key inclusion criteria (4 listed)
- 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);
Key exclusion criteria (2 listed)
- patients who have undergone previous therapy in the last three weeks;
- patients with a history of other cancer in the past two years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression free survival
Time frame: 6 months
time to first progression until the second one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Background: PubMed 26950035Abdallah 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.
- Results publication: PubMed 25258541Chinen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludmilla Chinen, PhD principal investigator
AC Camargo Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyosarcoma and Pleomorphic Liposarcoma, run by AC Camargo Cancer Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ludmilla Chinen, PhD (55 11 21895000 ext. 2776, ludmilla.chinen@cipe.accamargo.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983539, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.