# Presentation: 216742

## Cancer Clinical Central Participant Registry&caMATCH

- caBIG Project Summary
- February 20, 2004

## C3PR: Project Summary

- Sponsors:
- NCI Center for Bioinformatics
- Center for Cancer Research
- Clinical Trials Management Workspace
- Projects:
- C3PR: Cancer Clinical Central Participant Registry  caMATCH: Access of Patients to Trials

## What is the Participant Registry?

- A patient – participant centric view of clinical trials
- Association between any of the parties involved in a trial and the trial
- Patient: potential, screened, enrolled, former
- Referring Physician, Attending Physician
- Trial nurse, Social worker, PI, Family members, Guardians, etc
- A patient centric entry point to the Clinical Trial management systems
- A J2EE based application independent of the clinical trial system
- A system integrated with caCORE, caBIG infrastructure
- Potentially a National Registry of trial patients

## Needs Met by the Participant Registry

- Participant Centric access to clinical information
- Relationship management for participants and trials (Patient, Physicians, Trial Nurses, Social Worker, Family Members, Guardians, Principal Investigator,...)
- A tool to increase accruals
- Tie clinical research to other cancer research
- Integrative Cancer Research
- Tissues Banks, Pathology tools
- Facilitate collection of outcomes
- Infrastructure component for other services
- Single point of data entry and storage for sensitive information

## Stage of Maturity

- In the build stage for Release 2
- Target date Mid-March 2004
- First Deployment target:  The NCI Center for Cancer Research
- Primary features implemented:
- Access Clinical Trial System by Patient, regardless of study
- Oracle Remote Data Capture interface
- Register Trial Participants for CCR
- Track referring physicians and contacts
- Integrate with the Common Data Elements, a caCORE component
- Manage metadata of all information recorded
- Establish a foundation for HL7 messages
- Building block for caMATCH and CCADT

## Architectural Goals

- Tactical: Integrate well with NCICB’s C3D application
- Strategic: Allow for multiple clinical trials system interfaces in future releases
- Decouple the database from C3PR from any clinical database
- Isolate the interfaces modules
- Utilize industry supported specifications and open source
- Implement the J2EE multi tier architecture, Java, XML
- Ability to exchange information using HL7 messages (RIM 3.0)
- Ability to dynamically use Common Data Elements from caDSR
- Use the GUI standards for NCICB
- Ensure the platform addresses enterprise level of service requirements: Scalable, Reliable, Extendable, Maintainable, and Secure

## Infrastructure Integration 

- Use of Common Data Elements (current release)
- All data elements of C3PR will be in caDSR
- Classified as used by the C3PR
- All display elements are parameters
- Driven from a repository local to the application
- Loaded from the caDSR before a  release is build
- Stable for the duration of the release
- Use of common model for address/contact information
- Re-use of the models used by the DCP and CTEP
- Use of HL7
- Data elements are mapped to the HL7 messages (current release)
- Data exchanges will be via HL7 compliant messages (next release)

##  C3PR Pilot Configuration: Release 2 - March 2004

- Existing

- New

**LEGEND**

**NIH Perimeter**
**Fire Wall**

**Browser**

**Oracle RDBMS**
**CDR**

**Oracle RDBMS  9i**
**C3PR**

**Oracle RDBMS  8.1.7.2**
**Oracle Clinical**

**JBOSS Application Server **

**Oracle 9iAS**
**Application Server (R1)**

**C3PR**

**RDC**

**Jinitiator**

**Load of **
**Protocols**

**Patient**
**insertion**

**Registrations**

**Participants**

- Oracle
-  Forms

- Discoverer
- Web

**Look Ups**

**Hospital System**

**WINDOWS 2000**

**SOLARIS**

**SOLARIS**

**SOLARIS**

**Apache HTTP Server**

**Apache HTTP Server**

**Client**

**MS WINDOWS**

- HTTPS

- LDAP
- Service

- NCICB
- LDAP

- Discoverer
- Client

- Link

**caDSR**

**Load of **
**Metadata**

- caCORE
- API

**XML**

## C3PR: a Building Block in Clinical Research 

**Participant Registry**

## C3PR as Infrastructure

- Single database for all participants
- Message based information exchange with other applications and databases
- Integratable but decoupled
- Tie in with
- Admission, Transfer and Discharge modules
- Relationship management modules
- De-identification services and derivative research
**caMATCH**

## Extensions for caBIG : caMATCH

**Participant**
**Registry**

**Study **
**Registry**

**Protocol Info **
**Eligibility**
**Criteria**

**Participant**
**Consent, Contacts,**
**Demographics,**
**Participant provided data**

**Assisted Clinical Trials Search and Recruitment**
**caMATCH - BCT.ORG**

**CT or Hospital**
**Systems**

**Screening**
**Results,**
**Med Record**

## caMATCH: Patient and Research

**Matching **
**Algorithm**
**Agents**
**Data Store**
**Security**

**Patients,**
**Doctors**

**EMR**

**Profile**
**Consents**

**Journal**

**Researchers**

**Updated**
**Trial Info**

**Pre-matched**
**Patients**

**Direct**
**Communication**

**caMATCH: Patient and Research**

## caMATCH Scenario

- Empower the patient to manage their health and promote access to clinical trials
- PI and Institution stores and manages available trials
- With detailed, **structured, computable Eligibility Criteria**
- Managed by the PI
- Patient stores and manages patient information
- Patient provided, **patient friendly**, journaling and history features
- Potentially access to medical records if consented
- System matches by patient request
- Based on **hard data** not only text searches, map of ECs to patient information/record
- Patient initiates contact
- De-identified on both sides on first contact
- PI validates - screens requests
- Patient provides contact information => process starts

## caMATCH Status

- Prototype built by BCT.ORG, UCSF
- NCI commitment to assist
- Active direction from the UCSF and BCT.ORG Patient Advocates
- Project staffed
- Analysis and evaluation started
- Re-use of the C3PR and other NCICB infrastructure assets is evaluated
- A path to caBIG compliance is being mapped
- Cooperation with PDQ for data access and re-use
- Breast Cancer Trials most likely as a Pilot in 2004

## caMATCH Benefits

- Patient centric: encourage patients to manage their health
- Reach more patients or potential participants
- Provide patient support features (personal history, links, info)
- Patient controls their data and contacts
- Less hit and miss search for the appropriate trials
- Computable matching criteria
- Increase accuracy, better screening results
- Accrual tool for researchers
- More, wider pool of potential candidates
- Consent from the patient to be matched and contacted?
- More comprehensive database of trials with NCI help

## QUESTIONS

- Comments, feedback