NCT02960971

Brief Summary

To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

November 8, 2016

Last Update Submit

February 24, 2023

Conditions

Chronic Neuropathic Pain, PostoperativeChronic Pain, PostoperativeChronic Chemotherapy-induced Neuropathic PainChronic Chemotherapy-induced PainChronic Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Chronic Neuropathic Pain, Postoperative

    Neuropathic pain grading system, Finnerup et al. 2016 will be used.

    12 months after surgery

Secondary Outcomes (4)

  • Chronic Chemotherapy-induced Peripheral Neuropathy

    12 months after surgery

  • Chronic Chemotherapy-induced Neuropathic Pain

    12 months after surgery

  • Acute Postoperative Pain

    0-5 days after surgery

  • Area of peri-incisional hyperalgesia

    0-5 days after surgery

Interventions

Thoracic surgery for lung cancerPROCEDURE

Lung cancer resection performed via Video-assisted thoracoscopic surgery (VATS) and/or thoracotomy, including lobectomy, bilobectomy, pneumonectomy, resection of the tracheobronchial bifurcation, wedge resection, sleeve resection and combinations hereof.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for lung cancer resection at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark

You may qualify if:

  • Male and female subjects.
  • Age ≥18 years.
  • Patients scheduled for lung cancer resection performed via thoracoscopy and/or thoracotomy, including lobectomy, bilobectomy, pneumonectomy, resection of the tracheobronchial bifurcation, wedge resection, sleeve resection and combinations hereof.
  • Willingness and ability to comply with study procedures as judged by the site investigator/manager.
  • Expected availability for follow-up throughout the study, i.e., \~12 months.
  • Willingness to voluntarily sign and date the study-specific informed consent form.

You may not qualify if:

  • Mental incapacity or language barriers precluding adequate understanding of study procedures.
  • Current alcohol or substance abuse according to the site investigator's medical judgement.
  • Unsuitability for participation in the study for any other reason, e.g. due to a significant serious underlying condition (e.g. other cancer or AIDS), as determined by the site investigator/manager.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Danish Pain Research Center, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (3)

  • Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.

    PMID: 20876709BACKGROUND

  • Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.

    PMID: 27115670BACKGROUND

  • Sperandio G, Baudic S, Bennedsgaard K, Grosen K, Andersen IS, Finnerup NB, Albi-Feldzer A, Flor H, Nees F, Bouhassira D, Attal N. Somatic and psychological predictors of chronic postsurgical pain in cancer patients: a machine learning approach in a longitudinal two-centre study. Br J Anaesth. 2026 Jan 7:S0007-0912(25)00847-5. doi: 10.1016/j.bja.2025.12.002. Online ahead of print.

    PMID: 41506969DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Thoracic Surgical Procedures

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Nanna B Finnerup, DMSc

    Danish Pain Research Center, Aarhus University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 10, 2016

Study Start

January 2, 2017

Primary Completion

June 18, 2019

Study Completion

June 16, 2021

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

DK(2)