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.

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Key information

Conditions

Circulating Tumor Cells (CTCs) Neoplasm Metastasis Neoplasms Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mackay Memorial Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.
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:

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.
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 :

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

Treatment and study plan

Primary outcomes

Overall Survival

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

MiCareo Taiwan Co., Ltd.

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Sep 16, 2016
Registry last updated: Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed