NCT02983500

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2019

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

2.9 years

First QC Date

October 24, 2016

Last Update Submit

August 6, 2020

Conditions

Metastatic Pancreatic CancerNSCLC, Metastatic

Keywords

Patient Reported Outcome (PRO)

Outcome Measures

Primary Outcomes (1)

  • Rate of patients with loss of > 5 % body weight

    18 months

Secondary Outcomes (4)

  • Number of underweight patients

    12 months

  • General health-related quality of life assessment

    12 months

  • Fatigue assessment

    12 months

  • Cachexia assessment

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple sites all over Germany

Multiple Locations, Germany

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsCarcinoma, Non-Small-Cell LungNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Manfred Welslau, MD

    Medical practise for oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

December 6, 2016

Study Start

August 28, 2016

Primary Completion

July 24, 2019

Study Completion

July 24, 2019

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)