Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With Chemotherapy and Targeted Therapy

April 22, 2015 updated by: Li Zhang, Sun Yat-sen University

A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With 1st or 2nd Line Line Chemotherapy and Targeted Therapy

TITLE : A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC with 1st or 2nd line chemotherapy and targeted therapy

BACKGROUND : Circulating tumor cells (CTC) identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). CTC identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.

PRIMARY OBJECTIVE : To study the relationship between CTC count and clinical outcome of treatment (Overall response rate and Progression-free survival).

SECONDARY OBJECTIVES :To study the relationship between CTC and overall survival.

STUDY DESIGN : This is a prospective, observational study.

Duration of the inclusions: 12months.

SAMPLE SIZE : 1200 patients

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a prospective observational non-intervention study evaluating the dynamic CTC count during the chemotherapy and targeted-therapy. Patients provide written informed consent and pass the screening. Peripheral blood will be drawn before and after the treatment. Relationship between CTC count and clinical outcome will be analysed. The time points of blood drawing are set as following: for patients receiving chemotherapy, once prior to 1st cycle of chemotherapy, once 3 days prior to 2nd cycle of chemotherapy, posterior to 3th cycle (or less than 4th cycle) of chemotherapy and once when progressive disease (PD); for patients receiving targeted-therapy, once prior to treatment, once 1 month after treatment, and once when PD. The clinical outcome of treatment will be ultimately obtained.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Li Zhang, M.D.

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable or combined modality treatment) or metastatic (stage IV) non-small cell lung cancer, who will receive routine first or second line chemotherapy, or EGFR-TKI for those with EGFR sensitive mutant type.

Description

Inclusion Criteria:

  • Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable or combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
  • ECOG functional status≤2
  • Chemotherapy:According to routine 1st line doublet chemotherapy in clinical practice, Cisplatin or carboplatin combined with gemcitabine or paclitaxel or docetaxol or Vinorelbine were recommended. According to routine 2nd line chemotherapy in clinical practice,pemetrexed or docetaxol
  • Targeted therapy：According to clinical criteria, patients with EGFR-TKI sensitive mutant accept first line TKI therapy.
  • Patients must have measurable disease according to the RECIST (version 1.1) criteria
  • Patients with a life expectancy greater than 12 weeks
  • Written (signed) informed Consent to participate in the study

Exclusion Criteria:

  • Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
  • Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
  • Unwilling to write informed consent to participate in the study
  • Patients who is unwilling to accept the follow-up.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Treatment
Treatment: Chemotherapy or targeted therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Baseline CTC count
Time Frame: Two year
Two year

Secondary Outcome Measures

Outcome Measure
Time Frame
CTC count change
Time Frame: Two years
Two years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

Cyttel Biosciences Inc.

Investigators

  • Principal Investigator: Li Zhang, M.D., Sun Yat-sen University

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

April 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSCLCCTC-SUMS01

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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