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What are the inclusion criteria for outlier patients? TT

Category: Study Design

Labels: inclusion criteria, exclusion criteria

Creation date and Author: Astrid C., July 23rd 2025

Last Update and Author: NA

Related questions: 

  • Can I include deceased long-term survivors (Outliers)?
  • What are the inclusion and exclusion criteria for the outliers? 

 

Cf Protocol and Outlier Screening Tool

Inclusion Criteria

  1. Adult patient: patient over 18 years of age at diagnosis;
  2. Show a long-term survival i.e. an exceptional long survival of ≥ 5 years from stage IV diagnosis for metastatic PDAC, extensive SCLC and GBM-IDHwt;
  3. Availability of at least one tumor block sample

Indication-specific criteria

GBM IDH-wt

ES-SCLC

  • Diagnosis of glioblastoma according to the 2021 classification.
  • IDH1 and IDH2 wild type (wt) status: the patient will be included if IDH wt, excluded if IDH mutated.

NB: If IDH status is unknown, Cure51 will fund IDH1 testing by IHC and if necessary other analyses to validate the diagnosis.

Extensive stage definition: defined as cancer that has spread widely to the lung where the tumor is located, to the other lung, to thoracic lymph nodes located on the side of the thorax opposite to where the tumor is situated, or to other parts of the body.

Exclusion Criteria

  • Patient is under 18 years of age at diagnosis
  • No sample available
  • No survival beyond 5 years after stage IV diagnosis (extensive stage for SCLC, metastatic stage for PDAC)

Indication-specific criteria

mPDAC

GBM IDH-wt

ES-SCLC

The following histologies are excluded: 

  • adenosquamous carcinoma
  • hepatoid carcinoma
  • undifferentiated anaplastic carcinoma and medullary carcinoma
  • acinar cell carcinoma
  • neuroendocrine tumors
  • solid pseudopapillary neoplasm
  • pancreatoblastoma
  • serous cystadenocarcinoma
Mutated IDH1 and IDH2 status

The following histologies are excluded: 

  • combined SCLC with some areas of non-small cell lung cancer (NSCLC)
  • carcinoid tumors
  • typical and atypical
  • large cell neuroendocrine carcinoma of the lung)

NB: However, the fact that the patient has a history of cancer with another type of tumor is not an exclusion criterion, if they otherwise meet the inclusion criteria for one of the cohorts.

What is meant in the protocol is that the biopsy/surgery sample cannot be from a tumor that is not in the scope of tumor type from our study.

Specific cases 

  • If an outlier patient has passed away, but survived 5 years after stage 4 diagnosis, they can be included.
  • If an outlier patient has an OS of 55-59 months (<60 months), this case could be discussed (i.e. if a patient is going to become an outlier within 6 months)
  • If an outlier patient was diagnosed at a localized stage and relapsed to a metastatic stage then survived 60 months (5-years) after this stage, they can be included.
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