Detection of Circulating Tumor Cells in Peripheral Blood From Healthy Volunteers and Patients With Cancer

To address the challenges of isolating and analyzing rare cells, this study aims to validate technical diagnostic instrumentation, tests, protocols and analysis to correlate the number of circulating tumor cells present in whole blood for predicting cancer prognosis and treatment efficacy. Investigators propose to enroll and follow cohorts of cancer patients. Blood samples will be collected from these patients at regular intervals as determined by their doctors. The patient's disease progression will be monitored over the lifetime of this study. The specific aims are to isolate, enumerate and analyze the number of circulating tumor cells (CTCs) in patient blood using chip-based sorting, filtration and imaging techniques. Investigators will also use this study to optimize diagnostic instrumentation, test protocols and downstream CTC analysis. Investigators may also correlate the results of these tests with the prognosis of the patients as well as any clinical evidence (e.g. from radiological imaging scans). While investigators focus on prognosis in this study, these correlated tests potentially may also be valuable in future studies for early diagnosis and monitoring of cancer.

Study Overview

• Status: Completed
• Conditions: Circulating Tumor Cells (CTCs)

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

healthy volunteers and breast cancer patients

Description

Inclusion Criteria:

For inclusion in the first stage of the study, subjects must fulfill all of the following criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Patients diagnosed with stage 4 breast cancer or other types of cancer or chosen to be part of one of the negative control population cohorts.

For inclusion in the second stage of the study, subjects must fulfill all of the following criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Patients diagnosed with breast cancer or other types of cancer or chosen to be part of one of the negative control population cohorts.

Exclusion Criteria:

The following is regarded as a criterion for exclusion from the study and applicable to both 2 stages :

1. Subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
first stage; For the first stage, 60 healthy volunteers, 10 patients with stage 4 breast cancer and 10 patients with other types of cancer will be recruited.
second stage; For the second stage, approximately 65 breast cancer patients will be recruited.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	3 years

Collaborators and Investigators

• Sponsor: MiCareo Taiwan Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplastic Cells, Circulating
• Other Study ID Numbers: MCPZ12001J1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED