NGS and TME for Evidence-based Treatment of Pancreatic Ca... | NCT02767700

Studies
NGS and TME for Evidence-based Treatment of Pancreatic Cancer

NCT02767700

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Oct 24, 2023Actual

Enrollment

39Actual

Phase

Not provided

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Mar 25, 2018Actual

Completion Date

Aug 31, 2018Actual

First Submitted Date

Mar 8, 2016

First Submission Date that Met QC Criteria

May 9, 2016

First Posted Date

May 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2023

Last Update Posted Date

Oct 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The tumor tissue of patients with pancreatic cancer will be submitted to next-generation sequencing (NGS) and these data will be evaluated with an oncology treatment decision support (TDS) software tool that is a medicinal product class 1 (CE-marked). This software will make evidence-based suggestions for drugs likely to be effective, ineffective, or toxic (FDA approved biomarkers). For patients fit for second-line therapy, the resulting recommendations will be judged by the tumor board.

Detailed Description

Tumor tissue of patients (surgical resection, biopsy) will be used for SWEDAC-certified DNA extraction and NGS. Pseudonymised sequencing data will be fed into a TDS software tool (TreatmentMAP™, Molecular Health) and based on published evidence, suggestions will be made, graded into NCCN categories of approved drugs in indication or otherwise, clinical evidence or experimental. Same with anticipated inefficacy. In addition, FDA-approved biomarkers for toxicity will be analysed. This information is taken to the tumor board for making a decision whether this information is useful and eventually to recommend a treatment for a given patient.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

39Actual

Name	Type	Description	Arm Group Labels	Other Names
NGS	Genetic	Next generation sequencing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with technical success		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with actionable targets	actionable targets (effective, ineffective, FDA approved toxicity markers)	3 days

Other Outcomes

Measure	Description	Time Frame
Number of patients where NGS+TME generated information was used for treatment		1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age ≥ 18 years up to 75 years
Patient willing and able to provide informed consent
TreatmentMAP™ NGS/TME is ordered by the tumor board (MDT) under routine clinical practice
Diagnosis of a locally advanced, inoperable or metastatic pancreatic carcinoma, clinically and histologically verified according to the currently prevailing standards.
Patient received first line therapy according to applicable guidelines and/or standards (SoC)
Sufficient testing material available (e.g. tumor biopsy) to allow NGS/TME NGS panel testing.

Exclusion Criteria:

Patients with ongoing systemic infection,
Patients with immunodeficiency,
Patients with severe cardiovascular and pulmonary morbidity that might interfere with or preclude further systemic anticancer treatment,
Patients on full therapeutic anticoagulation.
Patients who, due to their clinical status, are not eligible for further systemic anticancer therapy (chemotherapy, immunotherapy etc.)
Patients who, due to their disease status are in need of immediate therapy and cannot wait for the result of the NGS/TME process.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with pancreatic adenocarcinoma

Sampling Method

Probability Sample

Name	Affiliation	Role
Johan Permert, MD PhD	Karolinska University Hospital	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28675654	Background	Malgerud L, Lindberg J, Wirta V, Gustafsson-Liljefors M, Karimi M, Moro CF, Stecker K, Picker A, Huelsewig C, Stein M, Bohnert R, Del Chiaro M, Haas SL, Heuchel RL, Permert J, Maeurer MJ, Brock S, Verbeke CS, Engstrand L, Jackson DB, Gronberg H, Lohr JM. Bioinformatory-assisted analysis of next-generation sequencing data for precision medicine in pancreatic cancer. Mol Oncol. 2017 Oct;11(10):1413-1429. doi: 10.1002/1878-0261.12108. Epub 2017 Aug 8.