Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenoma

Neoplastic Cells, Circulating

Prostatic Hyperplasia

Hyperplasia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasm Metastasis

Neoplastic Processes

Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before.

Blood draws, from peripheral veins, each time 2 tubes, each 5 ml.

Blood draws

Jun Qi, MD.

Jie Ding, MD.; Postdoc.

1. To elucidate the role of CTC detection in the evaluation of risk level in PCa patients, and establish a mathematic model for predicting the pathological status.
2. To explore the possible subtle change in CTC condition after radical prostatectomy.

1. Detect and evaluate the CTC status (a total of 3 times: 1 day before sugery, 3/12 months after surgery) for all of the PCa patients enrolled. Analyze the CTC result with PSA level, needle biopsy and radiological imaging information.
2. Analyze the difference in CTC amount/Epithelial-Mesenchymal ratio between patients in different D'Amico risk level(low/intermediate/high).
3. Establish a mathematic model based on the CTC results and pathological condition observed in operation (OC, organ confined; EPE, extraprostatic extension; SVI, seminal vesicle invasion; LNI, lymph node invasion), and compare this model with the latest version of Partin table.
4. Detect and compare the CTC and PSA level 3/12 months after surgery. Evaluate the radiological condition in 12 months after blood draw.

Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique

This step should be completed within the day when the peripheral venous blood is drawn.

The pathology section evaluation will be done by two pathologists independently. A third pathology expert will join to make a final decision if opposite results are given by the two pathologists.

The blood should be drawn together with that for CTC detection

Radiological evaluation should be conducted after the blood is drawn for CTC and PSA detection.

Shanghai Shen Kang Hospital Development Center

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Head of the Urology Department

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Herbal and Botanical

All Drugs and Chemicals

Cola

Subjects affected by Pancreatic carcinoma (PC) confirmed by tissue biopsy

Healthy Subject enrolled following colon cancer screening via colonoscopy

Detection and quantification of EMT-transcription factor mRNA levels in blood

Liquid biopsy

Luigi AG Laghi, MD, PhD

Luana Greco, MD, MSci

Luigi Laghi, MD

The present study is aimed at detecting and measuring mRNA levels of genes involved in epithelial to mesenchymal transition (EMT) in biological samples, i.e. in peripheral blood samples of pancreatic cancer (PC) patients and healthy controls, to determine the presence of disease, its progression and risk of recurrence.

The investigators first provided evidence that human pancreatic cancer (PC) cells can undergo EMT during local invasion, and that EMT transcription factors (i.e.Twist family basic helix-loop-helix transcription factor 1 (TWIST1)) are increased in the blood of PC patients. In addressing the relevance of EMT in the metastatic process, the prognostic role of M-like cancer cells entering into the circulation remains to be determined.

Currently, the notion that cancer disseminates via the circulation led to increased attention on the identification of circulating tumor cells (CTCs) in blood samples ("liquid biopsy"; LB), so far exclusively based upon epithelial (E) markers. However, an un-biased evaluation of CTCs, providing meaningful information for cancer diagnosis up to therapy, cannot exclude cells with M features. LB data show that circulating TWIST1, zinc finger E-box binding homeobox 2 (ZEB2) and E-Cadherin (CDH1) messenger ribonucleic acids (mRNA) are significantly and steadily increased in the blood of PC patients.These findings indicate that high levels of EMT players in the circulation efficiently discriminate PC patients, irrespectively of tumor resectability.

The present study is aimed at detecting and measuring mRNA levels of genes involved in epithelial to mesenchymal transition in biological samples, i.e. in peripheral blood samples of tumor patients, to determine the presence of disease, its progression and risk of recurrence.

Aim of the study is to depict the molecular profile of EMT-Transcription factor (EMT-TFs) variations in the blood of patients with early, intermediate or advanced PC, with respect to disease progression and delivered treatments.

Primary endpoint: to determ the stage, the remission or the progression of a pancreatic cancer in a pancreatic cancer affected subjects. This end-point comprising the step of assaying a biological sample from said subject for the presence of a panel of mRNAs encoding for transcription factors involved in epithelial to mesenchymal transition.

Secondary endpoint: to identify biomarkers suitable for the selection of patients amenable of responsiveness to medical and surgical treatment.

Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential

Data patent covered. No. Patent: EP13197367.9 - December 16, 2013

To determine the stage, the remission or the progression of a pancreatic cancer in a pancreatic cancer affected subject not administered with an appropriate antitumor treatment (e.g., neo-adjuvant therapy) comprising the step of assaying a biological sample from said subject for the presence of a panel of mRNAs encoding for transcription factors involved in epithelial to mesenchymal transition.

To identify biomarkers suitable for the selection of PC patients amenable of responsiveness to medical and surgical treatment.

IRCCS San Raffaele

Istituto Clinico Humanitas

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

CRC patients: primary, Stage I-IV (localized, node negative or node positive) colon carcinoma confirmed by tissue biopsy, and patients with advanced adenoma (including high-grade dysplasia, HGD).

Controls subjects as well as healthy clean colonoscopy subjects or with hyperplastic polyps, and healthy subjects with diminutive adenoma-low grade dysplasia (LGD) and with inflammatory bowel disease (IBD).

Luana Greco, MD

Laghi AG Luigi, MD, PhD

The present study is aimed at detecting and measuring mRNA levels of genes involved in epithelial to mesenchymal transition (EMT) in biological samples, i.e. in peripheral blood samples of colorectal cancer (CRC) patients and healthy controls, to determine the presence of disease, its progression and risk of recurrence.

The investigators first provided evidence that human colorectal cancer (CRC) cells can undergo EMT during local invasion, and that EMT transcription factors (i.e.Twist family basic helix-loop-helix transcription factor 1 (TWIST1)) are increased in the blood of CRC patients. In addressing the relevance of EMT in the metastatic process, the prognostic role of M-like cancer cells entering into the circulation remains to be determined.

Currently, the notion that cancer disseminates via the circulation led to increased attention on the identification of circulating tumor cells (CTCs) in blood samples ("liquid biopsy"; LB), so far mostly based upon epithelial (E) markers. However, an un-biased evaluation of CTCs, providing meaningful information for cancer diagnosis up to therapy, cannot exclude cells with M features. LB data show that circulating TWIST1 mRNAs are significantly and steadily increased in the blood of CRC patients. These findings indicate that EMT players in the circulation change during different phases of CRC progression.

The present study is aimed at detecting and measuring messenger ribonucleic acid (mRNA) levels of genes involved in epithelial to mesenchymal transition in biological samples, i.e. in peripheral blood samples of tumor patients, to determine the presence of disease, its progression and possibly the risk of recurrence, even in patients who will be treated with adjuvant therapy on clinical ground.

Aim of this study is to depict the molecular profile of EMT transcription factor (EMT-TFs) variations in the blood of patients with early, intermediate or advanced CRC, with respect to disease progression and delivered treatments.

Primary endpoint: To determ the stage, the remission or the progression of a colorectal cancer in a colorectal cancer affected subject not administered with an appropriate antitumor treatment (e.g., neo-adjuvant therapy) comprising the step of assaying a biological sample from said subject for the presence of a panel of mRNAs encoding for transcription factors involved in epithelial to mesenchymal transition.

Secondary endpoint: To identify biomarkers suitable for the selection of patients amenable of responsiveness to medical and surgical treatment.

"High Levels of EMT-TFs for the Diagnosis of Colorectal Cancer (CRC)"

To determine the stage, the remission or the progression of a colorectal cancer in a colorectal cancer affected subject not administered with an appropriate antitumor treatment (e.g., neo-adjuvant therapy) comprising the step of assaying a biological sample from said subject for the presence of a panel of mRNAs encoding for transcription factors involved in epithelial to mesenchymal transition.

To identify biomarkers suitable for the selection of CRC patients amenable of responsiveness to medical and surgical treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique	NCT02940977	Prostatic Neopl... Prostatic Adeno...	Blood draws	18 Years -	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential	NCT04323917	Pancreatic Canc...	Liquid biopsy	18 Years -	Istituto Clinico Humanitas
Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential	NCT04323917	Pancreatic Canc...	Liquid biopsy	18 Years -	Istituto Clinico Humanitas
"High Levels of EMT-TFs for the Diagnosis of Colorectal Cancer (CRC)"	NCT04323813	Colorectal Canc...	Liquid biopsy	18 Years -	Istituto Clinico Humanitas

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