Circulating Free DNA Analysis in Gastrointestinal Cancer, Genitourinary Cancer, Rare Cancer

May 17, 2019 updated by: Jeeyun Lee, Samsung Medical Center
The investigators planned this study to Patients with histologically confirmed metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy : Extra blood sample collection during routine blood sampling.

Study Overview

Status

Completed

Conditions

Detailed Description

Metastasis is a leading cause of cancer related deaths and is also one of the poorly understood aspects of cancer progression. During metastatic outgrowth, a cancer cell from a primary tumor locally invades the surrounding tissue, undergoes intravasation to enter hematogenous circulation and translocates to distant tissues through extravasation, survives and adapts to the foreign microenvironment leading to formation of a macroscopic secondary tumor (Figure 1, Chaffer and Weinberg (2011)). Several cancer therapies have been introduced in the last few decades from cytotoxics to targeted agents. However, these therapies fail to modulate growth of metastatic tumor cells which are often resistant, with most cancer patients succumbing to metastatic disease. There is a key need to further the understanding of metastatic disease in order to develop newer therapies. A central and somewhat unaddressed question is whether this acquisition of malignant traits occurs as an inevitable consequence of tumor progression or as an accidental product thereof. A widely accepted but not so well proven model of primary tumor formation suggests that cancer cells acquire a sequence of genetic and epigenetic alterations, each of which confers one or another form of increased fitness.

Figure 1: The metastatic cascade. Metastasis can be envisioned as a process that occurs in two major phases: (i) physical translocation of cancer cells from the primary tumor to a distant organ and (ii) colonization of the translocated cells within that organ. (A) To begin the metastatic cascade, cancer cells within the primary tumor acquire an invasive phenotype. (B) Cancer cells can then invade into the surrounding matrix and toward blood vessels, where they intravasate to enter the circulation, which serves as their primary means of passage to distant organs. (C) Cancer cells traveling through the circulation are Circulating free DNA. They display properties of anchorage-independent survival. (D) At the distant organ, Circulating free DNA exit the circulation and invade into the microenvironment of the foreign tissue. (E) At that foreign site, cancer cells must be able to evade the innate immune response and also survive as a single cell (or as a small cluster of cells). (F) To develop into an active macrometastatic deposit, the cancer cell must be able to adapt to the microenvironment and initiate proliferation.

It is somewhat accepted that tumors are clonally derived through unregulated growth of single cells that have likely accumulated the necessary number and types of heritable genetic and genomic alterations. Despite the monoclonal origin of cancer, the investigators see many tumors display a large amount of genetic, genomic and signaling heterogeneity. This heterogeneity is also believed to be one of the main drivers of metastasis. This heterogeneity has implications for understanding the disease progression landscape on one hand and diagnosis and treatment decisions on other. It is therefore of direct clinical importance to study the similarities and differences between the primary tumor and metastatic variants

Study Type

Observational

Enrollment (Actual)

396

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

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pathologically confirmed cancer patients

Description

Inclusion Criteria:

  • Patients older than 20 years
  • Patients with histologically confirmed metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy
  • Written informed consent form

Exclusion Criteria:

  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.

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

Cohorts and Interventions

Group / Cohort
metastatic Cancer
metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating tumor cell
Time Frame: 1years
To survey the mutation profiling of circulating free DNA in gastrointestinal cancer, genitourinary cancer, and rare cancer.
1years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mutation profiling of circulating free DNA
Time Frame: 1years
  1. To prospectively collect blood samples from patients and construct clinical database of gastrointestinal cancer, genitourinary cancer, rare cancer patients
  2. To define genotypes of circulating free DNA which will likely to response to anti-cancer therapy
1years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating Free DNA Analysis in Gastrointestinal Cancer, Genitourinary Cancer
Time Frame: From date of start of chemotherapy treatment by Circulating free DNA until the date of first progression or date of death from any cause.

The objective of this collaboration will be to evaluate the performance of next generation sequencing assay on mutation detection using matched plasma and primary tumor from various types of cancer.

The ultimate goal is to develop an ultra sensitive assay of mutation detection for early diagnosis, monitoring disease progression and treatment
From date of start of chemotherapy treatment by Circulating free DNA until the date of first progression or date of death from any cause.

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jeeyun Lee, MD,PhD, Division of oncologyu, Department of Medicine, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

September 11, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

February 9, 2018

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 17, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-06-076

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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Locations

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