Gastric CancerNCT06696963
Impact of TTC Following Neoadjuvant Chemotherapy on the Prognosis of LAGC
An observational study of Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
he present study retrospectively analyzed the clinicopathological data of 524 patients diagnosed with LAGC who underwent D2 radical gastrectomy after NACT between January 2010 and December 2021 at 2 centers. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 17 Apr 2024
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally Advnced Gastric Cancer who underwent D2 radical gastrectomy after NACT between January 2010 and December 2021
Who may be able to join
- (1) Locally advanced gastric cancer with preoperative clinical staging of cT2-4NxM0 before neoadjuvant chemotherapy. (2) No history of other malignant tumors. (3) No evidence of distant metastasis or invasion of adjacent organs. (4) Underwent gastrectomy after receiving neoadjuvant chemotherapy.
Who cannot join
- (1) History of prior gastrectomy. (2) History of acute cardiovascular diseases (such as cerebral or coronary artery injuries) within the past three months. (3) Emergency surgery. (4) Did not undergo postoperative adjuvant chemotherapy. (5) Lack of specific information regarding chemotherapy regimens. (6) Loss to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Time to Initiation of Postoperative Adjuvant Chemotherapy Following Neoadjuvant Chemotherapy on the Prognosis of Locally Advanced Gastric Cancer: a Multi-center Study
he present study retrospectively analyzed the clinicopathological data of 524 patients diagnosed with LAGC who underwent D2 radical gastrectomy after NACT between January 2010 and December 2021 at 2 centers. This study was conducted in accordance with the ethical principles outlined in the World Medical Association's Declaration of Helsinki. Informed consent was obtained from all patients and their legal guardians. All procedures were approved by the institutional review board.
Read the detailed description
This is a retrospective, multicenter study.
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Neoadjuvant chemotherapy, Adjuvant chemotherapy, Time to chemotherapy, survival
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year all-caused mortality, 3-year Gastric-Cancer Specific Motality
Survival status at 3 years: survival, death, survival with tumor
Measured: 3 years or 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start15 Mar 2024
- Primary completion15 Apr 2024
- Study completion17 Apr 2024
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 Fujian Medical 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
- Retrospective
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696963
- Sponsor's protocol ID
- 2024KY039
- Other IDs
- 2022QNA026
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 20 Nov 2024
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Time to Initiation of Postoperative Adjuvant Chemotherapy Following Neoadjuvant Chemotherapy on the Prognosis of Locally Advanced Gastric Cancer: a Multi-center Study
- ClinicalTrials.gov ID
- NCT06696963
- Acronym / sponsor ID
- 2024KY039
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Neoadjuvant chemotherapy, Adjuvant chemotherapy, Time to chemotherapy, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 20 Nov 2024 (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.
he present study retrospectively analyzed the clinicopathological data of 524 patients diagnosed with LAGC who underwent D2 radical gastrectomy after NACT between January 2010 and December 2021 at 2 centers. This study was conducted in accordance with the ethical principles outlined in the World Medical Association's Declaration of Helsinki. Informed consent was obtained from all patients and their legal guardians. All procedures were approved by the institutional review board.
Detailed description
This is a retrospective, multicenter study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally Advnced Gastric Cancer who underwent D2 radical gastrectomy after NACT between January 2010 and December 2021
Key inclusion criteria (1 listed)
- (1) Locally advanced gastric cancer with preoperative clinical staging of cT2-4NxM0 before neoadjuvant chemotherapy. (2) No history of other malignant tumors. (3) No evidence of distant metastasis or invasion of adjacent organs. (4) Underwent gastrectomy after receiving neoadjuvant chemotherapy.
Key exclusion criteria (1 listed)
- (1) History of prior gastrectomy. (2) History of acute cardiovascular diseases (such as cerebral or coronary artery injuries) within the past three months. (3) Emergency surgery. (4) Did not undergo postoperative adjuvant chemotherapy. (5) Lack of specific information regarding chemotherapy regimens. (6) Loss to follow-up.
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
3-year all-caused mortality, 3-year Gastric-Cancer Specific Motality
Time frame: 3 years or 36 months.
Survival status at 3 years: survival, death, survival with tumor
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 Nov 2024.
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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 Fujian Medical 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 1 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 Nov 2024. 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?
3-year all-caused mortality, 3-year Gastric-Cancer Specific Motality (time frame: 3 years or 36 months.). 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 20 Nov 2024.