NCT07466212

Brief Summary

The goal of this observational study is to see how type 2 diabetes affects quality of life in cancer patients receiving immunotherapy. We want to know if patients with diabetes have a greater decline in quality of life over six months compared to those without. The main question we aim to answer is: \- How does quality of life change over six months in patients with versus without diabetes? Participants will complete quality-of-life surveys at the start, then at 3 and 6 months. This will help us see if diabetes adds extra challenges during cancer treatment

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
920

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Mar 2026

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

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 Progress17%
Mar 2026Oct 2027

First Submitted

Initial submission to the registry

March 6, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

March 6, 2026

Last Update Submit

March 11, 2026

Conditions

CancerType 2 Diabetes

Keywords

Type 2 diabetesCancerImmunotherapyQuality of lifePatient-reported outcomesReal-world study

Outcome Measures

Primary Outcomes (1)

  • Change in EORTC QLQ-C30 Global Health Status score

    Change in health-related quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status scale. Scores range from 0 to 100, with higher scores indicating better global quality of life. The outcome compares changes from baseline between patients with type 2 diabetes and patients without diabetes receiving immune checkpoint inhibitor (ICI) therapy.

    Baseline, 3 months and 6 months

Secondary Outcomes (8)

  • Change in EQ-5D-5L Index Value

    Baseline to 3 months and 6 months

  • Change in EQ-5D-5L Visual Analogue Scale (EQ-VAS) score

    Baseline, 3 months and 6 months

  • Incidence of immune-related diabetes mellitus

    Within 12 months after initiation of ICI.

  • Hospital Admissions

    Within 6 months after initiation of ICI therapy.

  • Time to Treatment Failure

    Within 6 months after initiation of immune checkpoint inhibitor therapy

  • +3 more secondary outcomes

Study Arms (2)

Patients with type 2 diabetes

The patients have cancer and receive immunotherapy

Patients without diabetes

The patients have cancer and receive immunotherapy

Eligibility Criteria

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

Adult patients with solid malignancies initiating immune checkpoint inhibitor therapy in routine clinical practice, with and without pre-existing type 2 diabetes.

You may qualify if:

  • Age ≥18 years.
  • Histologically confirmed solid malignant tumor.
  • Planned treatment with ICI monotherapy or dual-ICI combination therapy (metastatic, adjuvant, or neo-adjuvant settings).
  • Previous systemic anticancer therapy other than ICI is allowed.
  • Ability and willingness to provide written informed consent and to complete HRQoL questionnaires.
  • Sufficient Danish language proficiency to read, and complete study questionnaires.

You may not qualify if:

  • Previous ICI treatment within 6 months.
  • Concurrent systemic anticancer therapy other than ICI.
  • Declines or does not provide informed consent.
  • Cognitive or physical impairment preventing valid consent or completion of patient-reported outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Onkologisk afdeling, Klinik Kirurgi og Kræftbehandling

Aalborg, 9000, Denmark

Location

Kræftafdelingen, Aarhus Universitetshospital

Aarhus, 8000, Denmark

Location

Afdeling for Kræftbehandling, Herlev Hospital

Herlev, 2730, Denmark

Location

Sygehus Lillebælt, Onkologisk afdeling Vejle

Vejle, 7100, Denmark

Location

Related Publications (4)

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PMID: 8433390BACKGROUND

  • Brahmer JR, Abu-Sbeih H, Ascierto PA, Brufsky J, Cappelli LC, Cortazar FB, Gerber DE, Hamad L, Hansen E, Johnson DB, Lacouture ME, Masters GA, Naidoo J, Nanni M, Perales MA, Puzanov I, Santomasso BD, Shanbhag SP, Sharma R, Skondra D, Sosman JA, Turner M, Ernstoff MS. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events. J Immunother Cancer. 2021 Jun;9(6):e002435. doi: 10.1136/jitc-2021-002435.

    PMID: 34172516BACKGROUND

  • Cortellini A, D'Alessio A, Cleary S, Buti S, Bersanelli M, Bordi P, Tonini G, Vincenzi B, Tucci M, Russo A, Pantano F, Russano M, Stucci LS, Sergi MC, Falconi M, Zarzana MA, Santini D, Spagnolo F, Tanda ET, Rastelli F, Giorgi FC, Pergolesi F, Giusti R, Filetti M, Lo Bianco F, Marchetti P, Botticelli A, Gelibter A, Siringo M, Ferrari M, Marconcini R, Vitale MG, Nicolardi L, Chiari R, Ghidini M, Nigro O, Grossi F, De Tursi M, Di Marino P, Queirolo P, Bracarda S, Macrini S, Inno A, Zoratto F, Veltri E, Spoto C, Vitale MG, Cannita K, Gennari A, Morganstein DL, Mallardo D, Nibid L, Sabarese G, Brunetti L, Perrone G, Ascierto PA, Ficorella C, Pinato DJ. Type 2 Diabetes Mellitus and Efficacy Outcomes from Immune Checkpoint Blockade in Patients with Cancer. Clin Cancer Res. 2023 Jul 14;29(14):2714-2724. doi: 10.1158/1078-0432.CCR-22-3116.

    PMID: 37125965BACKGROUND

  • Sharma P, Allison JP. Immune checkpoint targeting in cancer therapy: toward combination strategies with curative potential. Cell. 2015 Apr 9;161(2):205-14. doi: 10.1016/j.cell.2015.03.030.

    PMID: 25860605BACKGROUND

MeSH Terms

Conditions

NeoplasmsDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Christina B Ruhlmann, MD, PhD

    Onkologisk afd R, OUH

    STUDY CHAIR

  • Debbie M Madsen, MD

    Onkologisk afd R, OUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Debbie Maria Madsen, MD

CONTACT

+45 29801558debbie.maria.madsen@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(4)