C00-C97
Conditions
Interventions
Group 1: ANTICIPATE - solid tumor patients treated with immunomodulatory cancer therapies receive additional blood samples before the start of immunotherapy, 1-7 weeks after the start of immunotherap
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria o Informed consent o Hemoglobin in blood = 8g/dl • Inclusion criteria of existing trials from which samples/data will be used (only for patients from these trials) o ANTICIPATE (DRKS00022890) ? Main diagnosis belongs to C00-C97 according to ICD-10 (2016), Advanced and/or inoperable and/or metastatic (M1 according to TNM 8th edition, AJCC) ? Measurable disease according to RECIST 1.1 (2) ? Undergoing an immunotherapy in monotherapy or in combination with other cancer-specific therapies. o SIMMBAP ? Written informed consent (Appendix 4-5) ? Patients with pancreatic adenocarcinoma or at risk of developing pancreatic adenocarcinoma including: ? Germline mutation in BRCA1/2, PALB2, ATM, CDKN2A, PRSS1, STK11 ? Lynch Syndrome ? Peutz-Jeghers syndrome ? Chronic pancreatitis ? Family history of pancreatic or associated hereditary cancers (e.g. breast, ovarian) ? Pancreatic progenitor lesions: pancreatic intraepithelial neoplasia, intraductal papillary mucinous neoplasm, mucinous cystic neoplasm ? For pancreatic cancer patients chemotherapy treatment indicated o SARCIMMUNE (DRKS00036263) ? Histologically-proven soft tissue sarcoma ? Regional hyperthermia treatment indicated o Main diagnosis belongs to C00-C97 according to ICD-10 (2016) or genetic cancer risk, or positive family history for malignant disease o INVISIBLE: Undergoing an immunotherapy in monotherapy or in combination with other cancerspecific therapies. o SIMMBAP HD: Indication for pancreatic adenocarcinoma genetic risk factor testing due to pancreatic risk factor mutation in 1st or 2nd degree relative or positive family history o NUTRIPAC: fulfilling either cachexia criteria • weight loss >5% in the last 6 months OR • weight loss more than 2% in the last 6 months with BMI 15% in the last 6 months with BMI less than 23kg/m2 OR • weight loss >20% in the last 6 months with BMI less than 27kg/m2
Exclusion criteria
Exclusion criteria: • NCT ANTICIPATE: Adoptive effector cell therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study is exploratory in nature. The primary endpoint is the immune profile in peripheral blood mononuclear cells assessed by single cell RNA sequencing | — |
Secondary
| Measure | Time frame |
|---|---|
| Other endpoints include bulk or single cell genomics data (genotype, chromatin accessibility, methylations, bulk RNA and DNA sequencing), circulating nucleic acid sequencing, as well as tissue spatial gene expression, spatial mass spectrometry, and microscopy data. Clinical secondary endpoints include radiological responses based on quantitative assessment of cross-sectional imaging data and survival. Moreover, patient leukocytes will be profiled ex vivo in cell culture and in mouse models. | — |
Countries
Germany, Israel, Spain
Contacts
Public ContactThomas Walle
Universitätsklinikum Heidelberg
Outcome results
None listed