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OpenTrials
Completed

NCT Number: NCT04805099

Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease

Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. The investigators performed a retrospective multicenter review of medical records of patients with diverse tumor types and underlying AID who received checkpoint inhibitors at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG). The primary endpoint was progression-free survival (PFS).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hellenic Oncology Cooperative Group

Athens, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Patients with cancer
  • Patients with autoimmune disease
  • Treated at HeCOG-affiliated Departments of Oncology
  • Early-stage or metastatic

Exclusion criteria

  • diagnosis of the autoimmune disease after initiation of immunotherapy

Treatment and study plan

Checkpoint inhibitor

Drug

Treatment with checkpoint inhibitors in patients with preexisting autoimmune disease

Primary outcomes

  1. progression-free survival

    Time frame: Through the completion of the study, for an average of 6 months

Sponsors and collaborators

Lead sponsor

Hellenic Cooperative Oncology Group

Other

Registry information

Official study title

Real-world Safety and Efficacy Data of Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease: the Experience of the Hellenic Cooperative Oncology Group

Acronym: CIAD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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