Gastric CancerNCT05274464
A Recurrence Nomogram for Hepatoid Adenocarcinoma of the Stomach
An observational study of Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
This study aims to develop a nomogram to predict postoperative recurrence of HAS and guide individually tailored surveillance strategies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- How many people
- 261 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2004to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with primary HAS who had undergone curative-intent resection at 14 institutions in China from 2004 to 2019 were included.
Who may be able to join
- Patients who had undergone complete resection of a primary HAS between April 2004 and December 2019
Who cannot join
- Patients with metastatic disease, patients who had undergone palliative surgery, patients who had died within 30 days, and patients who were lost to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Recurrence Nomogram to Guide Surveillance Strategies After the Resection of Hepatoid Adenocarcinoma of the Stomach: a China Hepatoid Adenocarcinoma of the Stomach Study Group Database Study
This study aims to develop a nomogram to predict postoperative recurrence of HAS and guide individually tailored surveillance strategies.
Read the detailed description
Patients were included from the China Hepatoid Adenocarcinoma of the Stomach Study Group (China-HASSG) database, which comprises 14 tertiary referral centers. All the patients who had undergone complete resection of a primary HAS between April 2004 and December 2019 were included. First, univariate analysis was performed in Cox regression to identify the risk factors associated with RFS. Next, variables with P< 0.05 in univariable analysis were included in the multivariable model, and the forward likelihood ratio method was used for analysis to confirm the independent prognostic factors associated with RFS. Finally, based on the results of multivariable analysis, variables that achieved significance at P< 0.05 were selected to formulate a nomogram.
- Conditions
- Gastric Cancer
- Keywords
- Reurrence-free survival, Nomogram
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Reurrence-free survival
Reurrence-free survival was defined as the time interval from the date of the operation to the date of first recurrence or death from any cause.
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 posted10 Mar 2022
- Study start1 Apr 2004
- Primary completion31 Dec 2019
- Study completion31 Dec 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 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
- 261 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
- NCT05274464
- Sponsor's protocol ID
- HAS-GC-01
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 25 Mar 2022
- 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 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Recurrence Nomogram to Guide Surveillance Strategies After the Resection of Hepatoid Adenocarcinoma of the Stomach: a China Hepatoid Adenocarcinoma of the Stomach Study Group Database Study
- ClinicalTrials.gov ID
- NCT05274464
- Acronym / sponsor ID
- HAS-GC-01
- Conditions
- Gastric Cancer
- Keywords
- Reurrence-free survival, Nomogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2004 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Mar 2022 (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.
This study aims to develop a nomogram to predict postoperative recurrence of HAS and guide individually tailored surveillance strategies.
Detailed description
Patients were included from the China Hepatoid Adenocarcinoma of the Stomach Study Group (China-HASSG) database, which comprises 14 tertiary referral centers. All the patients who had undergone complete resection of a primary HAS between April 2004 and December 2019 were included. First, univariate analysis was performed in Cox regression to identify the risk factors associated with RFS. Next, variables with P< 0.05 in univariable analysis were included in the multivariable model, and the forward likelihood ratio method was used for analysis to confirm the independent prognostic factors associated with RFS. Finally, based on the results of multivariable analysis, variables that achieved significance at P< 0.05 were selected to formulate a nomogram.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with primary HAS who had undergone curative-intent resection at 14 institutions in China from 2004 to 2019 were included.
Key inclusion criteria (1 listed)
- Patients who had undergone complete resection of a primary HAS between April 2004 and December 2019
Key exclusion criteria (1 listed)
- Patients with metastatic disease, patients who had undergone palliative surgery, patients who had died within 30 days, and patients who were lost 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
Reurrence-free survival
Time frame: 3 year
Reurrence-free survival was defined as the time interval from the date of the operation to the date of first recurrence or death from any cause.
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 25 Mar 2022.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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 25 Mar 2022. 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?
Reurrence-free survival (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 25 Mar 2022.