MedTrace Logo

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

NCT02979470 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Colon Cancer Stage IIb
  • Rectum Cancer, Adenocarcinoma
  • Colon Cancer Stage IIIa
  • Colon Cancer Stage IIIc
  • Colon Cancer Stage IIIb

Sponsors & Collaborators

  • AC Camargo Cancer Center

    lead OTHER

Principal Investigators

  • Ludmilla Chinen, PhD · AC Camargo Cancer Center

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30
Completion
2019-09-30

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02979470 on ClinicalTrials.gov