Gastric CancerNCT03314649
Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer
An observational study of Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells in patients with gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Observational study
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2017to 1 Jan 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.
Who may be able to join
- Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
- PS (ECOG) of 0 or 1 and expected to survive more than 6 months.
- Written informed consent from the patient.
- Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.
Who cannot join
- 1. Female in pregnancy or lactation. 2. Patients participating in any other clinical trials currently，or participated in other trails within 1 months. 3. Patients with poor compliance or considered to be poor compliance.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study of Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer
Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells in patients with gastric cancer.
Read the detailed description
Gastric cancer (GC) remains one of the most common causes of cancer-related mortality worldwide. Surgery has always been considered as the most effective treatment for GC. Peritoneal metastasis is the common pattern of postoperative recurrence, especially patients with T4 stage or serosal invasion. What is worse, patients with peritoneal metastasis have a poor prognosis. However, it is often difficult to diagnose peritoneal metastasis at an early stage. As we know, the implantation of peritoneal free cancer cells exfoliating from serosa-invasive tumors is main reason of peritoneal seeding. Cytological examination of peritoneal lavage fluid is always performed to predict peritoneal micrometastases. However, more than half of patients with negative cytological results develop peritoneal recurrence. Low sensitivity and poor negative predictive value of this method have heralded the development of advanced techniques in detecting peritoneal free cancer cells.
In this study, novel genetic techniques will be used to detect mutated DNA of shed cancer cells in abdominal cavity. The present clinical trial aims to find a better tool to detect abdominal micrometastasis in GC patients, which may become a valid clinical index to predict postoperative relapse and direct treatment.
- Conditions
- Gastric Cancer
- Being tested
- Observational study
- Keywords
- Peritoneal Lavage, Gene Mutation, Peritoneal Metastasis,Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Lavage of the Peritoneal Cavity
| Study group | Role | What they receive |
|---|---|---|
| Observational study | Patients with gastric cancer and non-cancerous disease planned to have laparotomy Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
prognostic molecular markers
prognostic molecular markers
Measured: 3-year
Secondary outcomes (2)
OS
Overall survival
Measured: 3-year
DFS
Disease-free survival
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start21 Dec 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314649
- Sponsor's protocol ID
- CGCG003
- Status last verified
- May 2019
- First submitted
- 16 Oct 2017
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer
- ClinicalTrials.gov ID
- NCT03314649
- Acronym / sponsor ID
- CGCG003
- Conditions
- Gastric Cancer
- Keywords
- Peritoneal Lavage, Gene Mutation, Peritoneal Metastasis,Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 19 Oct 2017 (actual)
- 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.
Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells in patients with gastric cancer.
Detailed description
Gastric cancer (GC) remains one of the most common causes of cancer-related mortality worldwide. Surgery has always been considered as the most effective treatment for GC. Peritoneal metastasis is the common pattern of postoperative recurrence, especially patients with T4 stage or serosal invasion. What is worse, patients with peritoneal metastasis have a poor prognosis. However, it is often difficult to diagnose peritoneal metastasis at an early stage. As we know, the implantation of peritoneal free cancer cells exfoliating from serosa-invasive tumors is main reason of peritoneal seeding. Cytological examination of peritoneal lavage fluid is always performed to predict peritoneal micrometastases. However, more than half of patients with negative cytological results develop peritoneal recurrence. Low sensitivity and poor negative predictive value of this method have heralded the development of advanced techniques in detecting peritoneal free cancer cells.
In this study, novel genetic techniques will be used to detect mutated DNA of shed cancer cells in abdominal cavity. The present clinical trial aims to find a better tool to detect abdominal micrometastasis in GC patients, which may become a valid clinical index to predict postoperative relapse and direct treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational study | – | Other: Observational studyPatients with gastric cancer and non-cancerous disease planned to have laparotomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.
Key inclusion criteria (4 listed)
- Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
- PS (ECOG) of 0 or 1 and expected to survive more than 6 months.
- Written informed consent from the patient.
- Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.
Key exclusion criteria (2 listed)
- 1. Female in pregnancy or lactation. 2. Patients participating in any other clinical trials currently，or participated in other trails within 1 months. 3. Patients with poor compliance or considered to be poor compliance.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyLavage of the Peritoneal Cavity | Other | Observational study |
Primary outcome
prognostic molecular markers
Time frame: 3-year
prognostic molecular markers
2 secondary outcomes
OS
Time frame: 3-year
DFS
Time frame: 3-year
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 8 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fudan University at 1 site in China.
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 4 inclusion and 2 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 8 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 China. 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?
prognostic molecular markers (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2019.