NCT03124511

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 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

April 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

4 years

First QC Date

April 19, 2017

Last Update Submit

August 16, 2021

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 (2)

  • Chronic chemotherapy-induced peripheral neuropathy

    12 months after surgery

  • Chronic chemotherapy-induced neuropathic pain

    12 months after surgery

Interventions

Surgery for breast cancerPROCEDURE

Breast cancer resection performed via lumpectomy or mastectomy with or without sentinal node biopsy and axillary lymph node dissection.

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for breast cancer resection at the Department of Breast Surgery, Aarhus University Hospital, Aarhus, and the Breast Surgery Clinic, Viborg Regional Hospital, Viborg, Denmark.

You may qualify if:

  • Patients scheduled for breast cancer resection performed via lumpectomy (partial or segmental mastectomy) or mastectomy with or without sentinel lymph node biopsy and axillary lymph node dissection, and any 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

Breast Surgery Clinic, Viborg Regional Hospital

Viborg, 8800, 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

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

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

April 19, 2017

First Posted

April 21, 2017

Study Start

August 15, 2017

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

DK(2)