Heterogeneity of Dendritic Cells in Colon and Non-small Cell Lung Cancer

NCT04789252 | Recruiting DMC

• 1 other identifier: TUM-DC
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective study with the use of biological samples. The centers involved are the Thoracic Surgery and Surgery 1 Units of the San Gerardo Hospital in Monza.

Conditions

Non-small Cell Lung Cancer

Keywords

cancer; lung; colon cancer; dendritic cells

Outcome Measures

Primary Outcomes (2)

• Single cell bioinformatics analysis RNA-seq

  For the analysis of single-cell RNA-seq data we will exploit the most recent methodologies provided by both 10x Genomics and custom R / Python scripts to perform the identification and characterization of cell subsets.

  Until the end of the study (approximately 5 years).

• Single cell RNA-seq library preparation and sequencing.

  10,000 cells for each sample will be loaded on an instrument called Chromium 10X (10x genomics).

  Until the end of the study (approximately 5 years).

Secondary Outcomes (2)

• Spatial distributions of DC subtypes in the tumor microenvironment

  Until the end of the study (approximately 5 years).

• Correlation between subtypes of myeloid cells present in the tumor microenvironment and survival

  Until the end of the study (approximately 5 years).

Study Arms (1)

Patients with NSCLC or with colon cancer

The subjects are men or women with aged more than 18 years suffering from colon or lung cancer; The lesions are more than 1 cm. They are also able to give informed consent. The pathologist will sample the material and select the tissue that can be used for the experiment after having taken all that is needed for diagnostic purposes. The research sample will be placed in test tubes and kept on ice. It will then be sent to University of Milano-Bicocca laboratory whrere It will analyze approximately 60 patients for immunofluorescence studies and 4 patients for single cell transcriptomic analyzes

Biological: Bioinformatics analysis of single cell transcriptomics data

Interventions

Bioinformatics analysis of single cell transcriptomics data BIOLOGICAL

1. Sample collection: Myeloid cell purification + Single cell sequencing 2. Primary analysis: QC sequencing data + Reads alignment + UMI quantification 3. Bioinformatics analysis: Quality Control (Number of genes, UMI content,%mitochondrial genes, % riboprotein genes,Filtering low quality cells) + Normalization and scaling (Normalization, Remove unwanted sources of variation, HVG detection) + PCA Clustering Markers (PCA and PC selection, Clustering, t-SNE, Differential expression for markers identification) 4. Validation: FACS analysis + immunohistochemistry

Patients with NSCLC or with colon cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with NSCLC (primary tumor, adjacent healthy tissue, blood) or colon cancer (primary tumor, normal adjacent tissue, blood)

You may qualify if:

• men and women aged ≥18 years;
• clinical diagnosis confirmed by common investigations to establish the presence of colon or lung cancer;
• lesions\> 1 cm;
• legal capacity to give informed consent in accordance with ICH / EU GCP and national / local regulations.

You may not qualify if:

• pregnancy;
• presumed pregnancy;
• known coagulation defects;
• alcohol or drug abuse

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (2)

ASST Monza-C. CHIRURGIA GENERALE E D'URGENZA I

Monza, Italy

NOT YET RECRUITING

ASST Monza-Ospedale San Gerardo, S.C. Chirurgia Toracica

Monza, Italy

RECRUITING

Related Publications (5)

• Gornati L, Zanoni I, Granucci F. Dendritic Cells in the Cross Hair for the Generation of Tailored Vaccines. Front Immunol. 2018 Jun 27;9:1484. doi: 10.3389/fimmu.2018.01484. eCollection 2018.

  PMID: 29997628 BACKGROUND

• Bottcher JP, Reis e Sousa C. The Role of Type 1 Conventional Dendritic Cells in Cancer Immunity. Trends Cancer. 2018 Nov;4(11):784-792. doi: 10.1016/j.trecan.2018.09.001. Epub 2018 Sep 29.

  PMID: 30352680 BACKGROUND

• Hildner K, Edelson BT, Purtha WE, Diamond M, Matsushita H, Kohyama M, Calderon B, Schraml BU, Unanue ER, Diamond MS, Schreiber RD, Murphy TL, Murphy KM. Batf3 deficiency reveals a critical role for CD8alpha+ dendritic cells in cytotoxic T cell immunity. Science. 2008 Nov 14;322(5904):1097-100. doi: 10.1126/science.1164206.

  PMID: 19008445 BACKGROUND

• Eisenbarth SC. Dendritic cell subsets in T cell programming: location dictates function. Nat Rev Immunol. 2019 Feb;19(2):89-103. doi: 10.1038/s41577-018-0088-1.

  PMID: 30464294 BACKGROUND

• Mingozzi F, Spreafico R, Gorletta T, Cigni C, Di Gioia M, Caccia M, Sironi L, Collini M, Soncini M, Rusconi M, von Andrian UH, Chirico G, Zanoni I, Granucci F. Prolonged contact with dendritic cells turns lymph node-resident NK cells into anti-tumor effectors. EMBO Mol Med. 2016 Sep 1;8(9):1039-51. doi: 10.15252/emmm.201506164. Print 2016 Sep.

  PMID: 27406819 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples from patients with NSCLC: primary tumor, adjacent healthy tissue, blood. Samples from patients with colon cancer: primary tumor, normal adjacent tissue, blood.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Francesca Granucci

CONTACT

0264483553; francesca.granucci@unimib.it

Marco Scarci

CONTACT

3459364819; m.scarci@asst-monza.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 9, 2021
• Study Start: February 9, 2021
• Primary Completion: February 9, 2026
• Study Completion: February 9, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)