Phenotyping Liver Cancer Registry (PHELICAR)

May 15, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Large Scale Clinical Data Registry (CDR) to Accurately Identify the Specific Tumor Phenotypes to Better Diagnose and Predict Patient Outcome in HCC

The purpose of this study is the development of a content-based image retrieval (CBIR) platform, where validation studies will be conducted for liver disease subtyping and hepatocellular carcinoma (HCC) phenotyping on images for use as diagnostic and prognostic markers of outcome in conjunction with large scale data registries and advanced predictive machine learning methodologies. The proposed objectives will deliver one or more fit-for-purpose non-invasive imaging-based methodologies to evaluate the presence, activity and type of HCC in clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will advance through two distinct phases.

  • Phase 1 has two main stages: The first stage will identify unique tumor phenotypes based on the iBiopsy phenotyping platform which extracts image-based signatures corresponding to each individual phenotype and will assess the analytic/technical performance of the iBiopsy platform. Gaps in characterization of the analytic readout under varying conditions of image acquisition and the repeat variability under identical analytic conditions will be filled by the proposed design. Once a set of suitable tumor phenotypes have been identified they will advance to the characterization phase. This will be done by the evaluation of an initial representative specific dataset (e.g. hundreds of patients) for training (to discover) and validation (to test robustness). The second stage will complete a preliminary biological/clinical validation of the above phenotypes for diagnosis and disease subtyping. This includes the investigation of a large dataset (e.g. thousands of patients) CDR for training and validation, using histopathology data as the reference standard and the optimization of the imaging signatures using AI based learning methodologies.
  • Phase 2 also has two stages. The first stage of Phase 2 is to rigorously validate the candidate phenotypes emerging from Phase 1 for the diagnosis of subjects with HCC. The second stage of Phase 2 is to validate these select candidate phenotypes for prediction of outcome. These rigorous validations include using large CDR of patients with HCC (late stage biological/clinical validation).

Traditional medical image retrieval systems such as Picture Archival Systems (PACS) use structured data (metadata) or unstructured text annotations (physician reports) to retrieve the images. However, the content of the images cannot be completely described by words, and the understanding of images is different from person to person, therefore text-based image retrieval system cannot meet the requirements for massive images retrieval. In response to these limitations, CBIR systems using visual features extracted from the images in lieu of keywords have been developed. An important and useful outcome of these CBIR is the possibility to bridge the semantic gap, allowing users to search an image repository for high-level image features allowing the matching of image-based phenotype signatures extracted directly from the query medical image with phenotype signatures indexed in a registry.

The Median Technologies CBIR system uses patented algorithms and processes to decode the images by automatically extracting hundreds of imaging features as well as highly compact signatures from tens of thousands of 3D image patches computed across the entire image without the need for any prior segmentation. In addition to detailed phenotypic profiles which can be correlated with histopathology and genomic and plasmatic profiles, the system generates a unique signature for each tile providing a fingerprint of the "image-based phenotype" of the corresponding tissue. Using massively parallel computing methods, imaging biomarkers and phenotype signatures are extracted from a target image are then organized into clusters of similar signatures and indexed for real-time search and retrieval into schema-less (NoSQL) databases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2429

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75013
        • Assistance Publique - Hôpitaux de Paris (AP-HP) Groupe Hospitalier La Pitié-Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who were at risk of developing a liver disease that justified performing CT scan or MRI with contrast media and that had a liver biopsy, a tumor resection or a transplantation following imaging will be included in the protocol

Description

Inclusion Criteria:

Patients with visual liver disease who:

  • Have a lesion visualized on CT scans / MRI with histological confirmation (surgical resection, biopsy, transplant).
  • With a CT scan / MRI performed within 6 months prior to biopsy, surgical or transplant intervention.

Exclusion Criteria:

  • Patients that had CT scans / MRI taken more than 6 months prior to surgical intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patient with hepatocellular carcinoma
Phenotype signature database building Image features extraction and clustering
Device: Image features extraction and clustering

The image processing operations required for local content-based image feature extraction consist of two main tasks: 1) tiling the images in smaller VOIs, typically a small cube, whose size depends on the modality, on the image resolution and on the purpose of the content-based query, and 2) performing feature extraction operations on the VOIs.

The Feature Extraction Engine performs totally unsupervised, automatic and asynchronous extractions of features from the images, organizes and indexes them in a no-SQL database based on unique similarity metric. The results of this phase are a series of clusters of phenotype signatures.

Device: Phenotype signature database building
Since the clusters are self-organizing their pathophysiological meaning is not readily apparent and requires further analysis. The characterization of each cluster is performed by analyzing representative samples and their respective correlation with histopathology results. After a series of iterations, the clusters are organized to correlate with distinct tissue subtypes identified by their signature similarity. The final number of clusters is not known a priori and depends on the heterogeneity of the underlying imaging phenotypes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Specific tumor phenotypes
Time Frame: 2 years
accurately identify the specific tumor phenotypes to better diagnose and predict patient outcome in hepatocellular carcinoma
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hepatocellular carcinoma detection and characterization
Time Frame: 2 years
deliver one or more fit-for-purpose non-invasive imaging-based methodologies to evaluate the presence, activity and type of hepatocellular carcinoma in clinical practice
2 years
Repeatability and reproducibility
Time Frame: 2 years
Testing of phenotypes robustness by repeatability and reproducibility studies
2 years
Imaging phenotypes qualification
Time Frame: 2 years
: qualification of the imaging phenotypes against underlying pathophysiology and clinical outcome
2 years
Small lesion detection and characterization
Time Frame: 2 years
Description: deliver one or more fit-for-purpose non-invasive imaging-based methodologies to detect and characterize small lesions (< 2cm) (AUC 0.8)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Lucidarme, MD, Assitance publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP191046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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