Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis

Condition(s) studied

Study summary

This is a multicentric, observational study, including all European centres willing to take part. The multicentre nature is necessary for enhancing the generalisability of our results, and due to the rarity of this condition. The study is observational including both retrospective and newly diagnosed cases of CIC with an endoscopically/histologically-proven diagnosis. Detailed characteristics will be collected, with the aim of classifying the disorders from a clinical, endoscopic, and pathological point of view. Age, sex, localisation, and histology of tumour, stage of tumour, oncological response to immune checkpoint inhibitors-induced colitis, colonoscopy, histology, inflammatory parameters, and clinical manifestations will be assessed for each patient, as well as therapy and outcome.

The study will consist of 2 part: the first one will be retrospective, while the second one will be prospective al will include all incident patients diagnosed with CIC during the enrolment period.

Eligibility

Primary outcome measure(s)

• The primary endpoint is the rate of clinical remission defined as symptoms CTCAE grade 1 or less within 12 months after CIC diagnosis (at the last evaluation available when death occurs or at one year from diagnosis). — After baseline evaluation at the time of immune CIC diagnosis and four other evaluations after 3, 6, 9, and 12 months or until death if death occurred in the first 12 months.
  The rate of remission at 12 months will be estimated together with its 95% exact binomial 95% CI. The association of a series of predefined non-collinear baseline covariates and remission will be assessed using multivariable logistic regression. Huber-White robust standard errors will be computed to account for intra-centre correlation of measures. In case of death prior to the 12-month assessment, the last available measure will be used. A sensitivity analysis of the primary endpoint may be performed using multiple imputation of the primary endpoint for those patients who do not reach the 12 months assessment due to death or loss to follow-up. The following covariates will be considered: mild colitis vs those who need immunosuppressants, age \>70 years, female sex, BMI\>25, number of comorbidities, type of cancer (localisation, histology, and stage), type of ICI. A sensitivity analysis of the primary endpoint will be performed as described above with death considered as a failure.

Trial sites (1)

More Fondazione IRCCS Policlinico San Matteo di Pavia trials in Italy