Digestive System DiseasesNCT03488446
Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)
An observational study of Digestive System Diseases and Gastrointestinal Neoplasms, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive System Diseases, Gastrointestinal Neoplasms, Digestive System Neoplasms
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2017to 31 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: pathologically proven gastric cancer patients who receive preoperative CT and surgical resection in these hospitals.
Who may be able to join
- Age >18 years;
- Patients providing written informed consent;
- Pathologically proven gastric cancer scheduled to preoperative enhanced abdomen CT and undergo gastrectomy with type D2 lymphadenectomy;
- Has undergone > 64 multi-detector row CT within 14 days prior to surgical resection; .No receipt of preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy).
Who cannot join
- Preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy);
- Failed to receive preoperative enhanced abdomen CT or undergo gastrectomy with type D2 lymphadenectomy;
- Inavailable pathological results for local lymph node status;
- Inquality of CT images for feature extraction; .Patient quit.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515
Guoxin Li, M.D., Ph.D., +86-138-0277-1450, gzliguoxin@163.com
Yuming Jiang, M.D., Ph.D., +86-132-6826-6140, jiangymbest@163.com
About this study
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.
Read the detailed description
This is a prospective, multi-center trial conducted at 4 high-volume gastric cancer centers in China (Nanfang Hospital of Southern Medical University; Sun Yat-Sen University Cancer Center; First Affiliated Hospital, Sun Yat-Sen University; The Third Affiliated Hospital, Sun Yat-Sen University) designed to determine the predicted performance of radiomics-based prediction model for identifying metastasis of each station lymph nodes by enhanced CT for preoperative noninvasive assessment of the lymph node status in patients with gastric cancer. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.
- Conditions
- Digestive System Diseases, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Stomach Neoplasms
- Keywords
- Gastric Cancer, Radiomics, Computed Tomograpy, Lymph Node Metastasis, Prediction
- Medical subject headings
- Digestive System Diseases, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Stomach Neoplasms, Lymphatic Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological lymph node status of every station
Pathological lymph node status of each station is defined as lymph node metastasis exist or not
Measured: Pathologic evaluation will be performed for each patient within 1 week after surgery
Secondary outcomes (2)
Survival time
Disease-free survival and overall survival
Measured: Follow-up from the date of surgery to the date of death.
Lymph node stage (N stage)
Pathological lymph node stage after surgery (N0 stage: no lymph node metastassis; N1 stage: 1-2 lymph node metastasis; N2 stage: 3-6 lymph node metastasis; N3a stage: 7-15 lymph node metastasis;N3b stage: >15 lymph node metastassis)
Measured: Pathologic evaluation will be performed for each patient within 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start30 Aug 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Digestive System DiseasesStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Third Affiliated Hospital, Sun Yat-Sen University, The Third Affiliated Hospital of Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Guoxin Li, M.D., PH.D., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488446
- Sponsor's protocol ID
- GIPMCS-1701
- Status last verified
- Aug 2017
- First submitted
- 30 Sep 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.
PubMed 26579733Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach. Nat Commun. 2014 Jun 3;5:4006. doi: 10.1038/ncomms5006.
PubMed 24892406Huang YQ, Liang CH, He L, Tian J, Liang CS, Chen X, Ma ZL, Liu ZY. Development and Validation of a Radiomics Nomogram for Preoperative Prediction of Lymph Node Metastasis in Colorectal Cancer. J Clin Oncol. 2016 Jun 20;34(18):2157-64. doi: 10.1200/JCO.2015.65.9128. Epub 2016 May 2.
PubMed 27138577
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)
- ClinicalTrials.gov ID
- NCT03488446
- Acronym / sponsor ID
- GIPMCS-1701
- Conditions
- Digestive System Diseases, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Stomach Neoplasms
- Keywords
- Gastric Cancer, Radiomics, Computed Tomograpy, Lymph Node Metastasis, Prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Third Affiliated Hospital, Sun Yat-Sen University, The Third Affiliated Hospital of Southern Medical University
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 5 Apr 2018 (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 proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.
Detailed description
This is a prospective, multi-center trial conducted at 4 high-volume gastric cancer centers in China (Nanfang Hospital of Southern Medical University; Sun Yat-Sen University Cancer Center; First Affiliated Hospital, Sun Yat-Sen University; The Third Affiliated Hospital, Sun Yat-Sen University) designed to determine the predicted performance of radiomics-based prediction model for identifying metastasis of each station lymph nodes by enhanced CT for preoperative noninvasive assessment of the lymph node status in patients with gastric cancer. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pathologically proven gastric cancer patients who receive preoperative CT and surgical resection in these hospitals.
Key inclusion criteria (4 listed)
- Age >18 years;
- Patients providing written informed consent;
- Pathologically proven gastric cancer scheduled to preoperative enhanced abdomen CT and undergo gastrectomy with type D2 lymphadenectomy;
- Has undergone > 64 multi-detector row CT within 14 days prior to surgical resection; .No receipt of preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy).
Key exclusion criteria (4 listed)
- Preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy);
- Failed to receive preoperative enhanced abdomen CT or undergo gastrectomy with type D2 lymphadenectomy;
- Inavailable pathological results for local lymph node status;
- Inquality of CT images for feature extraction; .Patient quit.
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
Pathological lymph node status of every station
Time frame: Pathologic evaluation will be performed for each patient within 1 week after surgery
Pathological lymph node status of each station is defined as lymph node metastasis exist or not
2 secondary outcomes
Survival time
Time frame: Follow-up from the date of surgery to the date of death.
Lymph node stage (N stage)
Time frame: Pathologic evaluation will be performed for each patient within 1 week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Results publication: PubMed 26579733Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.
- Results publication: PubMed 24892406Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach. Nat Commun. 2014 Jun 3;5:4006. doi: 10.1038/ncomms5006.
- Results publication: PubMed 27138577Huang YQ, Liang CH, He L, Tian J, Liang CS, Chen X, Ma ZL, Liu ZY. Development and Validation of a Radiomics Nomogram for Preoperative Prediction of Lymph Node Metastasis in Colorectal Cancer. J Clin Oncol. 2016 Jun 20;34(18):2157-64. doi: 10.1200/JCO.2015.65.9128. Epub 2016 May 2.
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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.
Guoxin Li, M.D., PH.D. principal investigator
Nanfang Hospital, Southern Medical University
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 Digestive System Diseases and Gastrointestinal Neoplasms, run by Nanfang Hospital, Southern 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoxin Li, M.D., PH.D. (+86-138-0277-1450, gzliguoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological lymph node status of every station (time frame: Pathologic evaluation will be performed for each patient within 1 week after surgery). 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 NCT03488446, which also lists 3 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 5 Apr 2018.