Study of Blood Components as Probable Prognostic and Predictive Markers of Response to Treatment in Advanced Colon and Rectal Cancers (BMACR)

June 29, 2018 updated by: Ludmilla Thome Domingos Chinen, PhD, AC Camargo Cancer Center
The main reason of cancer-related mortality is the spread of cancer cells to distant sites (micrometastases). However, only a few small groups of tumor cells can metastasize by acquiring mechanism to decrease the immune response. Changes in the systemic inflammatory response to the tumor can be measured by blood-based parameters. In particular, the proportion of neutrophyls- lymphocytes (NL) has been evaluated for predicting the survival of patients with different types of cancer. The first strategy to treat colorectal cancer (CCR) is complete resection of the lesion. Nevertheless, some patients experience recurrence, probably due to residual micrometastases. We have demonstrated that analysis of some resistance proteins (Tyms / MRP1) in circulating tumor cells (CTCs) may predict treatment response in metastatic CCR patients (mCRC). We also note that the CTCs kinetics can show response to therapy. Patients with stage III disease in the colon / rectum, although showing high cure rate, generally fall locally or remotely and studies with blood markers in this group of patients is still scarce. Primary Objective: To investigate cells found in the blood (lymphocytes and neutrophils and CTCs) to verify if they can help in the choice of anti-neoplastic therapy in patients with advanced colon and rectum cancers. Secondary objectives: - to evaluate the influence of CTC kinetics in response to treatment of patients with advanced colon/rectum cancers; - to check the expression of treatment resistance, invasion and proliferation proteins (Tyms, TGF-βR, MMP-2, β-gal, Ki-67 and CD45) in CTCs and their correlation with response to treatment; - to check the mRNA expression of the same genes observed by immunocytochemistry in CTCs and their correlation with response to treatment; - to quantify CTCs, neutrophils and lymphocytes of patients included in this study and verify if there are correlation among their rates and progression-free survival. Methods: there will be collected 10 ml of blood of patients with advanced colon and rectal cancer for analysis of CTCs, lymphocytes / neutrophils. CTCs will be isolated, quantified and analyzed after separation by ISET method (Rarecells/France). The marker analysis of these cells will be done by immunocytochemistry and the gene expression will be assessed by RNAscope. The quantification of lymphocytes/neutrophils will be made by common blood count in Delboni laboratory. Expected Results: We propose to show that not only the count and the kinetics of CTCs, but also their molecular characteristics, can provide relevant information to clinicians. Hopefully, by quantification of neutrophils and lymphocytes, we will be able to identify new prognostic blood biomarkers that can direct clinicians to the best therapeutic choice.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

colon (EC III) or rectum (EC II and III) cancer patients

Description

Inclusion Criteria:- ECOG (Eastern Cooperative Oncology Group) Performance Status between 0 and 2; - patients undergoing surgery followed by adjuvant chemotherapy (locally advanced colon cancer) or initiating neoadjuvant chemotherapy followed by surgery (locally advanced rectal cancer); - disease measurable by RECIST criteria 1.1 (Response Evaluation Criteria in Solid Tumors); - medullary function assessed by peripheral blood sample considered normal; Renal and hepatic function tests up to 1.5 times the limit of normality.

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Exclusion Criteria:Patients younger than 18 years; -patients who have had surgery or surgical procedure in the last week; - patients who have had previous therapy in the last three weeks; - patients with previous history of another carcinoma in the last two years; - refuses to sign the TCLE

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 24 months
time between first blood collection for CTC´s analysis and first progression
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AC Camargo Cancer Center

Investigators

  • Principal Investigator: Ludmilla Chinen, PhD, AC Camargo Câncer Center

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP2141/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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