Esophageal Squamous Cell CarcinomaCMECCNCT06410677
Changhai Multimodal Esophageal Cancer Cohort
An observational study of Esophageal Squamous Cell Carcinoma, run by Wangluowei at 1 site in China.
Trial summary
The burden of esophageal squamous cell carcinoma (ESCC) in China is substantial, with 85% of the cancers being in the progressive stage. The treatment for advanced ESCC are extremely limited, and immunotherapy, represented by PD-1 inhibitors, has demonstrated a promising application potential. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- DNA Sequencing, RNA Sequencing
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2018to 1 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 110 patients with ESCC in the Changhai hospital
Who may be able to join
- Availability of Hematoxylin and Eosin (H\&E) stained images, molecular data obtained through RNA sequencing (RNA-Seq, DNA-seq), and comprehensive clinical information including patient age, gender, history of alcohol consumption, history of smoking, AJCC Tumor, Node, Metastasis Stage, specific location of oesophageal cancer occurrence, and history of reflux.
- The sample collection is restricted to cancerous tissue, encompassing both primary tumor samples and those from metastatic sites.
Who cannot join
- Patients diagnosed with adenosquamous carcinoma or presenting with a combination of other types of oesophageal cancers;
- Cases involving combined adenocarcinoma affecting the gastroesophageal junction;
- Individuals with high-grade tumors that have not penetrated the basement membrane, as confirmed by postoperative pathological examination;
- Subjects in whom postoperative pathology confirms an absence of residual malignant tissue.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Immune Infiltration Level and Immunotherapy Efficacy of Esophageal Squamous Cell Carcinoma Based on Multimodal Deep Learning
The burden of esophageal squamous cell carcinoma (ESCC) in China is substantial, with 85% of the cancers being in the progressive stage. The treatment for advanced ESCC are extremely limited, and immunotherapy, represented by PD-1 inhibitors, has demonstrated a promising application potential. However, the effectiveness of PD-1 inhibitors varies significantly among patients with different types of ESCC, and currently, there is no effective method to predict the response to PD-1 inhibitors. In this study, investigators aim to construct a multimodal deep learning-based model to predict the level of immune infiltration and the efficacy of immunotherapy for ESCC, integrating both pathological image features and clinical information of patients with ESCC, thereby enhancing the level of individualized and precise treatment for ESCC.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- DNA Sequencing, RNA Sequencing
- Keywords
- deep learning, Esophageal Squamous Cell Carcinoma, immune infiltration
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA Sequencing, RNA SequencingDiagnostic test
High-coverage Whole-Exome Sequencing sequencing of DNA samples from ESCC was performed.
RNA expression was analyzed using the NanoString PanCancer Immuno-Oncology 360TM Panel that includes a set of more than 700 genes involved in the main biological pathways of human immunity. These experiments were performed by the Genomics platform of Institut Curie. Total RNAs were used as templates.
| Study group | Role | What they receive |
|---|---|---|
| esophageal squamous cell carcinoma | Not described Receives: Diagnostic Test: DNA Sequencing, RNA Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogene signatures with predictive value for immunotherapy of ESCC
Measured: After undergoes surgery.
Secondary outcomes (1)
Prognosis and immunotherapy tolerance in ESCC patients
The prognosis was determined through follow-up, while tolerance to immunotherapy was anticipated utilizing gene sequencing methodologies.
Measured: Follow-up for at least 1 year after undergoing surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start13 Jun 2018
- Primary completion21 Oct 2022
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wangluowei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wangluowei, Changhai Hospital
- Investigators
- Luowei Wang, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410677
- Sponsor's protocol ID
- CMECC
- Acronym
- CMECC
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A planned initiative that includes sharing DNA and RNA sequencing data, alongside the provision of calculating code.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Immune Infiltration Level and Immunotherapy Efficacy of Esophageal Squamous Cell Carcinoma Based on Multimodal Deep Learning
- ClinicalTrials.gov ID
- NCT06410677
- Acronym / sponsor ID
- CMECC / CMECC
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- deep learning, Esophageal Squamous Cell Carcinoma, immune infiltration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- WangluoweiUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 13 May 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.
The burden of esophageal squamous cell carcinoma (ESCC) in China is substantial, with 85% of the cancers being in the progressive stage. The treatment for advanced ESCC are extremely limited, and immunotherapy, represented by PD-1 inhibitors, has demonstrated a promising application potential. However, the effectiveness of PD-1 inhibitors varies significantly among patients with different types of ESCC, and currently, there is no effective method to predict the response to PD-1 inhibitors. In this study, investigators aim to construct a multimodal deep learning-based model to predict the level of immune infiltration and the efficacy of immunotherapy for ESCC, integrating both pathological image features and clinical information of patients with ESCC, thereby enhancing the level of individualized and precise treatment for ESCC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| esophageal squamous cell carcinoma | – | Diagnostic Test: DNA Sequencing, RNA Sequencing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 110 patients with ESCC in the Changhai hospital
Key inclusion criteria (2 listed)
- Availability of Hematoxylin and Eosin (H\&E) stained images, molecular data obtained through RNA sequencing (RNA-Seq, DNA-seq), and comprehensive clinical information including patient age, gender, history of alcohol consumption, history of smoking, AJCC Tumor, Node, Metastasis Stage, specific location of oesophageal cancer occurrence, and history of reflux.
- The sample collection is restricted to cancerous tissue, encompassing both primary tumor samples and those from metastatic sites.
Key exclusion criteria (4 listed)
- Patients diagnosed with adenosquamous carcinoma or presenting with a combination of other types of oesophageal cancers;
- Cases involving combined adenocarcinoma affecting the gastroesophageal junction;
- Individuals with high-grade tumors that have not penetrated the basement membrane, as confirmed by postoperative pathological examination;
- Subjects in whom postoperative pathology confirms an absence of residual malignant tissue.
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 |
|---|---|---|
| DNA Sequencing, RNA SequencingHigh-coverage Whole-Exome Sequencing sequencing of DNA samples from ESCC was performed. RNA expression was analyzed using the NanoString PanCancer Immuno-Oncology 360TM Panel that includes a set of more than 700 genes involved in the main biological pathways of human immunity. These experiments were performed by the Genomics platform of Institut Curie. Total RNAs were used as templates. | Diagnostic test | esophageal squamous cell carcinoma |
Primary outcome
Immunogene signatures with predictive value for immunotherapy of ESCC
Time frame: After undergoes surgery.
1 secondary outcome
Prognosis and immunotherapy tolerance in ESCC patients
Time frame: Follow-up for at least 1 year after undergoing surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: Undecided. A planned initiative that includes sharing DNA and RNA sequencing data, alongside the provision of calculating code.
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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.
Luowei Wang study chair
Changhai Hospital
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 Esophageal Squamous Cell Carcinoma, run by Wangluowei 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 2 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 13 May 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?
Results are not available in the source record.
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?
Immunogene signatures with predictive value for immunotherapy of ESCC (time frame: After undergoes surgery.). 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 13 May 2024.