Gastric CancerNCT02067754
Circulating Free DNA Analysis in Gastrointestinal Cancer, Genitourinary Cancer, Rare Cancer
An observational study of Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 396 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Sep 2013to 9 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pathologically confirmed cancer patients
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Gastric Cancer
- Keywords
- The mutation profiling of circulating free DNA
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| metastatic Cancer | metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumor cell
To survey the mutation profiling of circulating free DNA in gastrointestinal cancer, genitourinary cancer, and rare cancer.
Measured: 1years
Secondary outcomes (1)
mutation profiling of circulating free DNA
- To prospectively collect blood samples from patients and construct clinical database of gastrointestinal cancer, genitourinary cancer, rare cancer patients
- To define genotypes of circulating free DNA which will likely to response to anti-cancer therapy
Measured: 1years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study start11 Sep 2013
- Primary completionJan 2018
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
- Investigators
- Jeeyun Lee, MD,PhD, Principal investigator, Division of oncologyu, Department of Medicine, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067754
- Sponsor's protocol ID
- 2013-06-076
- Status last verified
- May 2019
- First submitted
- 10 Feb 2014
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Lower EE etal. Impact of metastatic ER and PR status on survival. Breast Cancers and Treat. 90. 65-75. 2005. 2. Regitnig P et al. Change of Her-2/neu status in a subset of distant metastases from breast carcibnoma. J Pathol. 203 94) 918-26, 2004. 3. Cristofanilli M. Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med 351:781-91. 4. Riethdorf S, Fritsche H, Muller V, Rau T, Schindlbeck C, Rack B, Janni W, Coith C, Beck K, Janickje F, Jackson S, Gornet T, Cristofanilli M, Pantel K. Detection of circulating tumor cells in peripheral blood of patients with metastatic breast cancer: a validation study of the CellSearch system. Clin Cancer Res 13:920-8. 2007 5. Cristofanilli M, Broglio KR, Guarneri V, Jackson S, Fritsche HA, Islam R, Dawood S, Reuben JM, Kaum SW, Lara JM, Krishnamurthy S, Ueno NT, Hortobagyi GN, Valero V. Circulating tumor cells in metastatic breast cancer: biologic staging beyond tumor burden. Clin Breast Cancer 7:471-9, 2007.
Kim ST, Lee WS, Lanman RB, Mortimer S, Zill OA, Kim KM, Jang KT, Kim SH, Park SH, Park JO, Park YS, Lim HY, Eltoukhy H, Kang WK, Lee WY, Kim HC, Park K, Lee J, Talasaz A. Prospective blinded study of somatic mutation detection in cell-free DNA utilizing a targeted 54-gene next generation sequencing panel in metastatic solid tumor patients. Oncotarget. 2015 Nov 24;6(37):40360-9. doi: 10.18632/oncotarget.5465.
PubMed 26452027
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Free DNA Analysis in Gastrointestinal Cancer, Genitourinary Cancer, Rare Cancer
- ClinicalTrials.gov ID
- NCT02067754
- Acronym / sponsor ID
- 2013-06-076
- Conditions
- Gastric Cancer
- Keywords
- The mutation profiling of circulating free DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 11 Sep 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic Cancer | – | –metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologically confirmed cancer patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Circulating tumor cell
Time frame: 1years
To survey the mutation profiling of circulating free DNA in gastrointestinal cancer, genitourinary cancer, and rare cancer.
1 secondary outcome
mutation profiling of circulating free DNA
Time frame: 1years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Background1. Lower EE etal. Impact of metastatic ER and PR status on survival. Breast Cancers and Treat. 90. 65-75. 2005. 2. Regitnig P et al. Change of Her-2/neu status in a subset of distant metastases from breast carcibnoma. J Pathol. 203 94) 918-26, 2004. 3. Cristofanilli M. Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med 351:781-91. 4. Riethdorf S, Fritsche H, Muller V, Rau T, Schindlbeck C, Rack B, Janni W, Coith C, Beck K, Janickje F, Jackson S, Gornet T, Cristofanilli M, Pantel K. Detection of circulating tumor cells in peripheral blood of patients with metastatic breast cancer: a validation study of the CellSearch system. Clin Cancer Res 13:920-8. 2007 5. Cristofanilli M, Broglio KR, Guarneri V, Jackson S, Fritsche HA, Islam R, Dawood S, Reuben JM, Kaum SW, Lara JM, Krishnamurthy S, Ueno NT, Hortobagyi GN, Valero V. Circulating tumor cells in metastatic breast cancer: biologic staging beyond tumor burden. Clin Breast Cancer 7:471-9, 2007.
- Derived from this study: PubMed 26452027Kim ST, Lee WS, Lanman RB, Mortimer S, Zill OA, Kim KM, Jang KT, Kim SH, Park SH, Park JO, Park YS, Lim HY, Eltoukhy H, Kang WK, Lee WY, Kim HC, Park K, Lee J, Talasaz A. Prospective blinded study of somatic mutation detection in cell-free DNA utilizing a targeted 54-gene next generation sequencing panel in metastatic solid tumor patients. Oncotarget. 2015 Nov 24;6(37):40360-9. doi: 10.18632/oncotarget.5465.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeeyun Lee, MD,PhD principal investigator
Division of oncologyu, Department of Medicine, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor cell (time frame: 1years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02067754, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.