Patient Reported Outcomes Registry in Patient With Cancer... | NCT02983500

Studies
Patient Reported Outcomes Registry in Patient With Cancer Cachexia

NCT02983500

Sponsor

iOMEDICO AG

Status

Completed

Last Update Posted

Aug 7, 2020Actual

Enrollment

253Actual

Phase

Not provided

Conditions

Metastatic Pancreatic Cancer
NSCLC, Metastatic

Interventions

Not provided

Countries

Germany

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

Aug 2020

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

Aug 28, 2016Actual

Primary Completion Date

Jul 24, 2019Actual

Completion Date

Jul 24, 2019Actual

First Submitted Date

Oct 24, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 6, 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

Aug 6, 2020

Last Update Posted Date

Aug 7, 2020Actual

Name	Class
Chugai Pharma Europe Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.

Detailed Description

The PRO Xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia.

Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT questionnaires, respectively.

These data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general QoL, fatigue and cachexia and the evaluation of malnutrition.

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

No data available

No data is available for this block.

Enrollment

253Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of patients with loss of > 5 % body weight		18 months

Secondary Outcomes

Measure	Description	Time Frame
Number of underweight patients	BMI < 20 kg/qm at start or during observation.	12 months
General health-related quality of life assessment	At baseline, throughout and at the end of the study with SF 12 questionnaire.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of NSCLC UICC stage IIIB/IV or pancreatic cancer UICC stage III/IV
Start of the first line palliative systemic treatment
Ability to read and understand German
Written informed consent

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients diagnosed with locally advanced and unresectable or metastatic NSCLC (UICC Stage IIIB/IV) or locally advanced and unresectable or metastatic pancreatic cancer (UICC stage III/IV) at start of their first-line palliative systemic treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manfred Welslau, MD	Medical practise for oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Multiple sites all over Germany		Multiple Locations			Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided