C25, C34, C71 C25 C34 C71
Conditions
Interventions
Group 1: Case group 1: Patients with an exceptionally high survival time of at least 5 years in metastatic pancreatic ductal adenocarcinoma (PDAC).
Analyses are based on the following data:
clinical
Sponsors
Cure51
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: In order to be included in the study outliers must fulfil the following criteria: 1. the subject must be 18 years or older at the time of 18 years or older at the time of sample collection. 2. belong to one of the three defined cohorts cohorts: PDAC, GBM-IDHwt and SCLC. 3. long-term survival is defined as exceptionally long survival from the time of the time of diagnosis of stage IV diagnosis. For PDAC and SCLC a survival period of = 5 years and for for GBM-IDHwt of = 3 years. 4. at least one tumour block of sufficient sufficient quality and quantity for analyse the data mentioned in 10. must be available. For this it is necessary that associated clinical data are available in which any treatments prior to the sample collection, as well as all types of treatment over the course of the disease are documented. 5. the samples for PDAC and SCLC must beat least 5 years old and for GBM-IDHwt must be at least 3 years old. In order to be included in the study the control samples must fulfil the following criteria: 1. the subject must be 18 years or older at the time of 18 years or older at the time of sample collection. 2. belong to one of the three defined cohorts cohorts: PDAC, GBM-IDHwt and SCLC as well as the corresponding match with the associated outliers based on criteria such as age, gender, stage and otherand other prognostic factors 3. the survival time from the time of the diagnosis of stage IV should be the median overall survival (see 5.) ± 25 %. 4. there must be at least one tumour block of sufficient quality and quantity to analyse the data mentioned in 10. must be available. For this it is necessary that associated clinical data are available in which any treatments prior to the sample collection, as well as all types of treatment over the course of the disease are documented.
Exclusion criteria
Exclusion criteria: Samples are excluded under the following conditions excluded: Cohort A (PDAC): For other histologies, such as: - adenosquamous carcinoma - hepatocellular carcinoma - anaplastic undifferentiated carcinoma - medullary carcinoma - acinar cell carcinoma - neuroendocrine tumours - solid pseudopapillary neoplasm - pancreatoblastoma - serous cystadenocarcinoma Cohort B (GBM-IDHwt): IDH-mutated are excluded. Cohort C (SCLC): For other histologies such as: - combined SCLC with areas of non-small cell lung cancer (NSCLC) lung cancer (NSCLC) - typical and atypical carcinoid tumours - large cell
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the confirmation of the status as an outlier or control case. Only data and samples already collected as part of routine treatment are used for the ROSALIND study. These samples were archived in pathological laboratories in accordance with the statutory retention periods and can therefore be used for research purposes. No additional analyses, interviews or examinations are required. All clinical data used originate from the relevant medical records and were collected during routine appointments or treatments. The clinical data is recorded in a digital case report form. The tumour samples already taken are sent to the Gustave Roussy Cancer Campus for analysis. | — |
Countries
France, Germany, Spain
Contacts
Public ContactLucas Röleke
Charité Comprehensive Cancer Center
Outcome results
None listed