Solid TumorRIREPNCT04079283
Radiomics of Immunotherapeutics Response Evaluation and Prediction
An observational study of Solid Tumor and Predictive Cancer Model, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study aims to investigate the feasibility and efficiency of CT radiomic analysis which serves as a high through-put analytical strategy applied to image big-data resource in evaluating and predicting the response of immunotherapeutics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Predictive Cancer Model
- What is being tested?
- Clinical, Semantic and Radiomic
- How many people
- 285 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 25 Feb 2020
- 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: Inpatient records in each involved research center from 2017.01.01 to 2019.12.31.
Who may be able to join
- Patients with histopathological or cytopathological confirmed solid tumor (including metastatic solid tumor).
- Patients ≥ 18 years of age on the day of baseline CT scan.
- Patients received immune checkpoint inhibitors (ICI) monotherapy or combined with chemotherapy in any line of treatment.
- Patients with at least one measurable target lesion of which minor axis was greater than 15mm and without any local treatment.
- Female with a negative pregnancy test, or male who agree to use barrier methods of contraception through the therapy period.
- Patients with a Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1.
- Patients underwent follow-up CT scans with an 6-9-week interval until 365 days after baseline CT scan.
- Patients with baseline and follow-up CT scans which meet the following conditions: a) Spiral computed tomography device of General Electric Healthcare or Siemens with greater than 16 rows of detectors ; b) Peak kilovoltage: 120kV; c) Dose: auto or fixed; d) Slice resolution: not less than 512 pixels multiply 512 pixels; e) Scanning range: from supraclavicular region to 2cm below the costophrenic angle for thorax, and from diaphragm to pubic symphysis for abdomen; f) contrast-enhanced scan utilizing nonionic low- or iso-osmolar contrast agent and including arterial phase, venous phase and delayed phase at least.
Who cannot join
- Patients received any kinds of cytotoxic drugs or experimental drugs 2 weeks before enrollment.
- Patients meet the contraindications of contrast-enhanced CT scan.
- Patients who were not suitable for continuous follow-up CT scans.
- Patients with severe myocardial infarction confirmed by ECG or left ventricular ejection fraction(LVEF) less than 40% or glomerular filtration rate(GFR) less than 45ml/min.
- Patients who cannot tolerate immunotherapy or with serious immune-related adverse response.
- Patients with severe interstitial pneumonia confirmed by baseline CT scan.
Show all 9Show fewer
- Patients who cannot complete follow-up examinations scheduled by study design.
- Patients with AIDS or positive serum HIV antibodies.
- Patients with a CT scan presenting extremely low signal noise ratio or too much artifacts at any timepoint.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute And Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: Radiomics of Immunotherapeutics Response Evaluation and Prediction in Solid Tumor: A Multicenter Diagnostic Study
This study aims to investigate the feasibility and efficiency of CT radiomic analysis which serves as a high through-put analytical strategy applied to image big-data resource in evaluating and predicting the response of immunotherapeutics. A multi-center retrospective diagnostic test has been designed for this aim to compare the predictive performance of clinical model, qualitative model incorporating semantic CT features and image-based quantitative radiomic model. The reference standard of therapeutic effect is determined by the latest evaluation result utilizing iRECIST within 365 days after recruited. This study intends to enroll 400 participates who had been diagnosed with advanced somatic solid tumor confirmed by histo- or cyto-pathological examination and were planning to receive immunotherapy.
- Conditions
- Solid Tumor, Predictive Cancer Model
- Being tested
- Clinical, Semantic, Radiomic
- Keywords
- Response Evaluation Criteria in Solid Tumors, Computed Tomography, Radiomics, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClinicalDiagnostic test
Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.)
SemanticDiagnostic test
Also called Radiological
Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.)
RadiomicDiagnostic test
Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Patients who has received mono-therapy of immune checkpoint inhibitor. Receives: Diagnostic Test: Clinical; Diagnostic Test: Semantic; Diagnostic Test: Radiomic | |
| Combined therapy | Patients who has received immune checkpoint inhibitor combining chemotherapy. Receives: Diagnostic Test: Clinical; Diagnostic Test: Semantic; Diagnostic Test: Radiomic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the receiver operating characteristic curve (ROC)
Area under curve (AUC) of each diagnostic model
Measured: 6 months and 1 year since course start (365 days)
Secondary outcomes (2)
Disease Control Rate
Disease Control Rate of immunotherapy
Measured: 6 months and 1 year since course start (365 days)
Incidence
Incidence of immune-related adverse events
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Chest Hospital, Shandong Tumor Hospital, West China Hospital, First Affiliated Hospital of Zhejiang University, Sun Yat-sen University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Liaoning Cancer Hospital & Institute, Hubei Cancer Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- Zhaoxiang Ye, M.D, Ph.D, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079283
- Sponsor's protocol ID
- IIT0100
- Acronym
- RIREP
- Status last verified
- Jun 2019
- First submitted
- 1 Sep 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics of Immunotherapeutics Response Evaluation and Prediction in Solid Tumor: A Multicenter Diagnostic Study
- ClinicalTrials.gov ID
- NCT04079283
- Acronym / sponsor ID
- RIREP / IIT0100
- Conditions
- Solid Tumor, Predictive Cancer Model
- Keywords
- Response Evaluation Criteria in Solid Tumors, Computed Tomography, Radiomics, Immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Tianjin Chest Hospital, Shandong Tumor Hospital, West China Hospital, First Affiliated Hospital of Zhejiang University, Sun Yat-sen University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Liaoning Cancer Hospital & Institute, Hubei Cancer Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 6 Sep 2019 (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 investigate the feasibility and efficiency of CT radiomic analysis which serves as a high through-put analytical strategy applied to image big-data resource in evaluating and predicting the response of immunotherapeutics. A multi-center retrospective diagnostic test has been designed for this aim to compare the predictive performance of clinical model, qualitative model incorporating semantic CT features and image-based quantitative radiomic model. The reference standard of therapeutic effect is determined by the latest evaluation result utilizing iRECIST within 365 days after recruited. This study intends to enroll 400 participates who had been diagnosed with advanced somatic solid tumor confirmed by histo- or cyto-pathological examination and were planning to receive immunotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | – | Diagnostic Test: Clinical, Diagnostic Test: Semantic, Diagnostic Test: RadiomicPatients who has received mono-therapy of immune checkpoint inhibitor. |
| Combined therapy | – | Diagnostic Test: Clinical, Diagnostic Test: Semantic, Diagnostic Test: RadiomicPatients who has received immune checkpoint inhibitor combining chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient records in each involved research center from 2017.01.01 to 2019.12.31.
Key inclusion criteria (8 listed)
- Patients with histopathological or cytopathological confirmed solid tumor (including metastatic solid tumor).
- Patients ≥ 18 years of age on the day of baseline CT scan.
- Patients received immune checkpoint inhibitors (ICI) monotherapy or combined with chemotherapy in any line of treatment.
- Patients with at least one measurable target lesion of which minor axis was greater than 15mm and without any local treatment.
- Female with a negative pregnancy test, or male who agree to use barrier methods of contraception through the therapy period.
Key exclusion criteria (9 listed)
- Patients received any kinds of cytotoxic drugs or experimental drugs 2 weeks before enrollment.
- Patients meet the contraindications of contrast-enhanced CT scan.
- Patients who were not suitable for continuous follow-up CT scans.
- Patients with severe myocardial infarction confirmed by ECG or left ventricular ejection fraction(LVEF) less than 40% or glomerular filtration rate(GFR) less than 45ml/min.
- Patients who cannot tolerate immunotherapy or with serious immune-related adverse response.
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 |
|---|---|---|
| ClinicalClinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.) | Diagnostic test | Combined therapy, Monotherapy |
| SemanticAlso: RadiologicalSemantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.) | Diagnostic test | Combined therapy, Monotherapy |
| RadiomicRadiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.) | Diagnostic test | Combined therapy, Monotherapy |
Primary outcome
Area Under the receiver operating characteristic curve (ROC)
Time frame: 6 months and 1 year since course start (365 days)
Area under curve (AUC) of each diagnostic model
2 secondary outcomes
Disease Control Rate
Time frame: 6 months and 1 year since course start (365 days)
Incidence
Time frame: Through study completion, an average of 1 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 2 Apr 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Solid Tumor
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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Zhaoxiang Ye, M.D, Ph.D study chair
Tianjin Medical University Cancer Institute and 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 Solid Tumor and Predictive Cancer Model, run by Tianjin Medical University Cancer Institute and Hospital 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 8 inclusion and 9 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 2 Apr 2020. 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?
Area Under the receiver operating characteristic curve (ROC) (time frame: 6 months and 1 year since course start (365 days)). 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 2 Apr 2020.