Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplastic Cells, Circulating

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasm Metastasis

Neoplastic Processes

Laboratory studies will be performed at baseline; Cycle 1, Day 1; Cycle 1, Day 7; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 6, Day 1; Cycle 12, Day 1.

Wafik S El-Deiry, MD, PhD

The study will enroll patients with metastatic colorectal cancer receiving chemotherapy. A total of approximately 22 cc of blood will be drawn during various chemotherapy infusions. Additional proposed laboratory studies may unravel important biological insights into the relationship of circulating tumor cell genomic and genetic profiles as they compare to the primary tumors. Additionally the investigators hope to gain an understanding of potential subgroups of patients that have very high numbers of circulating tumor cells or those with early relapse of circulating tumor cells after early reduction of circulating tumor cell numbers.

Metastatic colorectal cancer (mCRC) has a five year survival of \<10% and is the cause of death of nearly 50,000 individuals in the United States each year. Current first and second line therapies for mCRC include FOLFOX, XELOX, or FOLFIRI in combination with Bevacizumab or Cetuximab or Panitumumab, as well as Xeloda, camptosar or infusional 5-FU within various less intensive regimens for patients who cannot tolerate full-dose chemotherapy. Current practice involves evaluation of response by imaging at 2-3 months after initiation of therapy. Recent studies have demonstrated that the number of circulating tumor cells (CTCs) in the blood of patients with mCRC has independent prognostic value in terms of reflecting disease burden as well as indicating response to therapy. The use of CTC counts offers the possibility of predicting response in treated patients at an earlier time than through standard means by using CT scans. The investigators hypothesize that subsets of CTCs with cancer stem cell (CSC) markers or other known prognostic markers may improve the prognostic value of CTC evaluation in the course of therapy of patients with mCRC. The protocol will use Veridex CellSearch technology and will when possible compare this to other emerging technologies including microfluidic devices that can isolate CTCs or GFP-expressing adenoviruses that replicate in telomerase-expressing epithelial tumor cells ex-vivo. The protocol will enroll 200 patients with metastatic colorectal cancer receiving therapy. Additional proposed laboratory studies may unravel important biological insights into the relationship of CTC genomic and genetic profiles as they compare to the primary tumors. Additionally the investigators hope to gain an understanding of potential subgroups of patients that have very high numbers of CTCs or those with early relapse of CTC after early reduction of CTC numbers. The impact of this research may be in better prediction of response to mCRC therapy so that patients can be treated with second line or other experimental therapy if they are unlikely to respond to their current therapy as predicted by CTC evaluation.

Blood will be drawn at 7 different time intervals to analyze CSC and other prognostic markers on circulating tumor cells.

Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells

Prevalence of Stem Cell and Prognostic Markers in Circulating Tumor Cells of Patients With Metastatic Colorectal Cancer Undergoing Chemotherapy

Correlate the presence of stem cell markers and prognostic markers on circulating tumor cells with response to therapy for advanced colorectal cancer, as well as overall survival

Evaluate the primary tumor if available for stem cell markers and prognostic markers. Perform genomic analysis of CTC DNA. Compare genomic analysis of primary tumor and CTC DNA. Evaluate CTC gene expression profiles and compare with primary tumor profiles. Evaluate emerging microfluidic devices in pilot studies that use drops of blood for CTC analysis.

Milton S. Hershey Medical Center

Rare Diseases

Carcinoma

Stomach Neoplasms

Carcinoma, Signet Ring Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Stomach Cancer

Diffuse Gastric Cancer

There were no special interventions for the two groups.

Without any intervention

Gastric signet ring cell carcinoma (GSRCC) possesses unique epidemiology and pathogenesis in the field of cancer, but its incidence is low. Unfortunately, there is currently a lack of systematic research focusing on the prognostic proteomic features of GSRCC. Given this knowledge gap, this study aims to comprehensively characterize the proteomic landscape of GSRCC using a reliable and reproducible DIA-PCT method. This study objectives include characterizing the heterogeneity of GSRCC, performing molecular typing, identifying potential biomarkers and therapeutic targets, and providing a resource for stratified analysis of GSRCC. To achieve these goals, the investigators selected a cohort of 112 GSRCC patients from a pool of over 10,000 gastric cancer patients and conducted a proteomic analysis using the DIA-PCT method. This meticulous approach revealed four novel proteomic subtypes of GSRCC, each exhibiting unique molecular characteristics. Additionally, the investigators discovered that PRDX2 and DDX27 can serve as predictive biomarkers for GSRCC, which were further validated in an independent cohort of 75 GSRCC patients. Furthermore, the investigators paid particular attention to the MLT-GSRCC subgroup and identified three distinct proteomic clusters among MLT-GSRCC patients. Subtype 2 within this subgroup demonstrated the poorest prognosis. Through a rigorous screening process, the investigators determined potential targets for the treatment of GSRCC. In conclusion, these findings contribute to the investigators understanding of the heterogeneity of GSRCC and provide valuable resources for future clinical stratification and targeted treatment strategies.

Biological samples are used for proteomic analysis.

Mechanism of Gastric Signet Ring Cell Carcinoma Based on Microproteomics

This study does not involve drug clinical trials but focuses on ensuring the confidentiality of patient information. To protect patient privacy, a coding system was used instead of real names when entering patient information such as names and ages. Each patient was assigned a study identification number upon enrollment. Throughout the entire study, only the main researchers in the research team have the authority to access the true personal data of patients obtained from the electronic database (such as names and ages), and it is strictly prohibited to circulate or share this information. During the publication of the research article, the main researchers in the research team will use sample coding to replace patient privacy information (such as names) to achieve de-identification. Additionally, the protection of personal information for study participants must be maintained throughout the entire research process, and it is strictly forbidden to circulate or leak such information.

The samples diagnosed as GSRCC by pathology were selected as the samples with signet ring cell content \> 70% as judged by 2 pathologists of associate chief physician or above and without previous radiotherapy and chemotherapy. Tumor tissues and paired nat were collected from the same patient at the time of tumor resection and stored in formalin-fixed paraffin embedding (FFPE). Liquid chromatography-mass spectrometry (LC-MS) was used to detect the proteomics in the samples. The proteins in the samples were extracted, and the proteomics in the samples was detected by LC-MS. Qualitative and quantitative analysis was performed to detect the types and content of proteins in the samples.

Zhejiang Cancer Hospital

Secretary of the party committee

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Sangmyung Woo, MD

This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.

Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.

* Quantification and monitoring of KRAS mutations Using droplet digital PCR in ctDNA extracted from collected patient samples.
* Correlation analysis of KRAS mutation results with clinical data.

Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.

* Gene panel composition for pancreatic cancer therapeutic target determination and monitoring.
* A panel was performed using gDNA and ctDNA of tumor tissue collected from pancreatic cancer patients.
* Comparative analysis of panel results and quantitative KRAS mutations and evaluation of clinical applicability.

Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy

Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.

Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.

National Cancer Center, Korea

Chief, Senior Scientist

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Somatostatin

Hormones

Hormone Antagonists

30 patients (18-80 years, males and females) affected by histologically-proven neuroendocrine neoplasms, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic (GEP) tract, candidate to medical therapy.

Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (18-80 years, males and females)

According to current ENETS guidelines, patients will be treated by somatostatin analogs or chemotherapy, recommended respectively as first line therapy in neuroendocrine tumours or neuroendocrine neoplasms.

Somatostatin analog; chemotherapy

Andrea M Isidori, MD, PhD

Elisa M Giannetta, MD, PhD

Elisa Giannetta, MD, PhD

Antongiulio Faggiano, MD, PhD

Mary Anna Venneri, PhD

Maria Grazia Tarsitano, MD, PhD

Giulia Puliani, MD

Tiziana Feola, MD

Franz Sesti, MD

Francesca Sciarra, PhD

This is a multicentre, controlled, observational prospective study on new biomarkers, as immune profiling, angiogenetic markers and circRNA from TEPs in the diagnosis and in the evaluation of treatment response in pulmonary and gastro-entero-pancreatic NENs.

Neuroendocrine Neoplasm (NEN) are heterogeneous disease in terms of origin, localization and clinical presentation. Annual incidence of NEN is increasing in the last 30 years, even if the reasons underlying this rise have not been completely identified.

Many biomarkers have been used in the diagnosis and follow-up of patients with NEN. In non-functioning NEN general tumor markers, such as chromogranin A (CgA) and neuron specific enolase (NSE), are commonly used but their sensibility and specificity are quite low.

Recently, high-throughput tissue microarray and immunohistochemistry assessments have been performed to observe the expression pattern of new potential markers for NEN. In order to overcome limitations of tissue acquisition, the use of liquid biopsies has been advocated. It has been reported that tumor-educated platelets (TEPs) may easily enable blood-based cancer diagnostics. TEPs take up tumor-derived secreted membrane vesicles containing RNAs, of which circular RNAs (circRNAs) that can serve as a potential biomarker source for cancer diagnostics. This innovative approach in cancer detection has not yet been transferred to the NEN field.

Flow cytometric analysis furnishes important insights into the immune status by providing information about the numbers and phenotypes of the immune cells, which are known to be altered in many types of neoplasms. In NEN, leukocytes subpopulations and peripheral blood mononuclear cells (PBMCs) are not been completely investigated but immunological alterations could represent a signal of neoplastic spread.

Inflammatory and angiogenetic pathways' involvement in NEN behavior has recently received increasing attention. It is well known that NEN are known to be highly vascularized neoplasms and somatostatin analogues (SSA), used as first line drugs for most well differentiated NEN, can reduce tumour proliferation by various direct and indirect mechanism including the inhibition of angiogenesis.

Tumor angiogenesis is a complicated process consisting of several steps, the angiogenesis cascade, regulated by endogenous and exogenous factors, including the system Angiopoietin-1 (Ang-1) and -2 (Ang-2) / Tie2 and Prokineticins. These systems are involved in neoplastic angiogenesis and inflammation in various types of cancer. Despite these evidences, the role of inflammatory and angiogenic factors in NEN detection and follow-up has not been completely clarified.

The aim of the study is to evaluate immune profiling, angiogenetic markers and circularRNA sequencing in patients affected by locally advanced or metastatic pulmonary or GEP NENs and controls. Moreover, NENs patients will be evaluated also after 1 and 3 months of first line medical treatment.

Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)

Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study

Modification of sTie (soluble Tie2) after treatment

Comparison of basal levels of sTie between patients and controls

Validation of the use of circular RNAs sequencing from tumor educated platelets (TEPs) in NETs diagnosis, through the comparison between patients and controls

Modification in circular RNAs sequencing from tumor educated platelets (TEPs) in patients after treatment

Comparison of basal level of other circular and cellular angiogenesis mediators between patients and controls (Angiogenic factors: ANG1, ANG2, FGF1, FGF2, NRP1, NRP2, VEGFA, VEGFB, VEGFC, HIF1A, NOS3, PROK1, PROK2; Cytokines: CCL11, CCL2, CXCL1, CXCL10, CXCL5, CXCL6, CXCL9, IL1B, IL6, TNF; Receptors and other angiogenic factors: VEGFR1, VEGFR2, TIE2, PDGFR, TGFBR, MMP14, MMP2, MMp9, TIMP1, TIMP2, TIMP3, PROKR1, PROKR2)

Modification of other circular and cellular angiogenesis mediators in patients after treatment (Angiogenic factors: ANG1, ANG2, FGF1, FGF2, NRP1, NRP2, VEGFA, VEGFB, VEGFC, HIF1A, NOS3, PROK1, PROK2; Cytokines: CCL11, CCL2, CXCL1, CXCL10, CXCL5, CXCL6, CXCL9, IL1B, IL6, TNF; Receptors and other angiogenic factors: VEGFR1, VEGFR2, TIE2, PDGFR, TGFBR, MMP14, MMP2, MMp9, TIMP1, TIMP2, TIMP3, PROKR1, PROKR2)

Quatification of peripheral blood mononuclear cells (PBMC) subpopulations in patients and controls

Modification of peripheral blood mononuclear cells (PBMC) subpopulations in patients after treatment

Comparison of basal serum level of classical neuroendocrine markers (chromogranin a and neuron specific enolase) between patients and controls

Modification of classical neuroendocrine markers (chromogranin a and neuron specific enolase) in patients after treatment

Frequencies and severity of infectious diseases will be evaluated by modified Infectious Diseases Questionnaire (GNC). This questionnaire includes questions on infectious diseases of upper and lower respiratory tract, gastrointestinal tract, skin and urogenital tract contracted during the previous 12 months. Questions investigate on the number and duration of infections, necessity of antibiotic or antifungal therapy, hospital stay and days of absence from work. Final score represents the frequency of infections. Moreover, some questions investigate possible susceptible or protective factors for infectious diseases: vaccinations, use of corticosteroids, concomitant diseases, previous appendectomy, tonsillectomy, adenoidectomy, splenectomy or thymectomy.

Quality of life will be evaluated by the Physical Component score and the Mental Component score of the self-administered questionnaire SF-36-Item Health Survey questionnaire. This questionnaire measures eight scales: physical functioning, role physical, bodily pain, general health (physical component) and vitality, social functioning, role emotional, mental health (mental component).

Interpretation of the score will be the following: at each item of the questionnaire corresponds a percentage value (from 0% to 100%). The average of the single items constitutes the scale total percentage (from 0% to 100%); missing data are not considered during calculation. High score defines a more favorable health state.

University of Roma La Sapienza

Full Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Zhenmin Lei, MD

This proposal seeks to retain "discard" pieces of human gynecologic tissues and "discard" ascites fluid collected during normal surgical procedures, along with corresponding blood samples and urine, for research involving prognostic markers of disease/cancer. The specific aims of the proposal include:

1. To collect "discard" pieces of benign, pre-malignant and malignant gynecologic tissues, "discard" ascites fluid and, when possible, corresponding blood and urine specimens from patients undergoing:

   1. hysterectomy
   2. excisions of cervical dysplasia and/or venereal warts, and
   3. therapeutic excisional surgeries to remove gynecologic disease/cancer (uterine, ovarian and lower female genital tract).
   4. paracentesis for the symptomatic relief of ascites fluid accumulation (distention).
2. To collect pre-operative blood and urine from patients along with pre- operative blood work drawn for clinical evaluation.
3. De-identify the patients from their donated tissue, blood and urine specimens by assigning a laboratory identification number.
4. Rapidly process and store the collected specimens to preserve biological integrity. (RNA, DNA and proteins)
5. Collect and record the patient's demographic and medical information into a research database under the assigned lab number only.
6. Assess the specimens for prognostic markers of gynecologic disease/cancer by molecular techniques such as DNA arrays,immunohistochemistry and ELISA.

During the last two decades, cancer research has shifted from using cell lines and animal models to directly using human tissue. This is especially true for research focused on premalignancies for which there are few good animal models. Research utilizing human tissues and sera not only addresses many issues/questions of medical research that cannot be evaluated in cell lines and/or in animal models of human disease, but it also provides a system to test the relevance of these findings to human diseases. Various biologic and genetic changes that occur in the developmental stages of human neoplasia can be identified and analyzed using human tissues.

Research using human tissues and sera is making great strides in the effort to define possible markers of developing neoplasia and will promote the design of targeted cancer treatments and possible prevention. It is important to link research findings in tissue and blood specimens to the clinical outcome of patients with malignancy so we can pinpoint when and where, during the course of cancer development, molecular changes occur.

Many malignancies of the female genital tract may arise in more than one location, either synchronously or metachronously, giving rise to the concept of a "field" effect of carcinogenesis. By collecting tissue from multiple epithelial sites (sampled by the physician) it is possible to compare the molecular changes seen in preinvasive to those that occur in invasive neoplasia for differential expression profiles of potential markers. If protein markers are identified in cells present in the diseased tissue we can check the patient's serum and urine to see if the proteins can be detected. This information will enable us to screen and possibly identify these protein markers in patient serum and urine to correlate with the presence of a premalignant or malignant state.

Malignant ascites is excess fluid that accumulates in the space between the membranes lining the abdomen and abdominal organs, otherwise known as the peritoneal, or abdominal cavity. Malignant ascites typically occurs because of a disease, infection, or cancer in the peritoneal cavity that produces excessive fluid. Ascites fluid accumulation is very common in gynecologic cancers, especially ovarian. If protein markers are identified in the cells present in the diseased ascites fluid we may be able to correlate these markers with metastasis of the disease/cancer and possibly help prevent the spread of several gynecologic cancers.

Prognostic Markers of Gynecologic Cancers

James Graham Brown Cancer Center

University of Louisville

Professor

Colonic Neoplasms

Anti-Infective Agents

Herbal and Botanical

Formaldehyde

Cola

Immunoscore® is a tissue-based immune test that measures the host's immune response at the site of the tumor. It is performed on formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from resections of localized colon cancer. The test uses whole slide imaging and artificial intelligence algorithms for assessment of the type, density, and location of T cells in FFPE tumor sections to determine an individual Immunoscore® for each patient.

Immunoscore Colon Test

Camila M Moniz, PhD

Ingrid P Barbosa

Lucila S Rocha, MD

Mariana B Siqueira, MD

Paulo M Hoff, PhD

Fernando A Soares, PhD

The proposed study is a bidirectional analytical study, composed of a retrospective and a prospective cohorts. Patients with stage II - III colorectal cancer undergoing oncological surgery will be analyzed. The study will include a convenience sample of 100 individuals. Fifty cases will be included retrospectively and fifty prospectively.

The study aims to evaluate the benefit of using the Immunoscore test as a predictor of recurrence in patients with operated stage II-III colon tumors. It will also be evaluated the impact on oncologic decision and costs.

Colorectal cancer resection surgical biospecimen

Role of Immunoscore® in Stage II-III Colorectal Cancer

Impact of Immunoscore stratification on tumor recurrence at 2 years

Impact of Immunoscore stratification on DFS at 5 years

Impact of Immunoscore stratification on OS at 5 years

Impact of Immunoscore stratification on DFS in right and left tumors at 3 years

Impact of Immunoscore stratification on OS in right and left tumors at 3 years

Percentage of patients who had an indication for adjuvant therapy through the evaluation of medical prescriptions

Correlation of Immunoscore stratification with the KRAS, NRAS and BRAF status

Difference in monetary value due to Immuno Score stratification and chemotherapy indication

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells	NCT01286883	Colorectal Canc...		18 Years -	Milton S. Hershey Medical Center
Mechanism of Gastric Signet Ring Cell Carcinoma Based on Microproteomics	NCT05985577	Gastric Cancer Signet Ring Cel...	Without any int...	-	Zhejiang Cancer Hospital
Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy	NCT04241367	Pancreas Adenoc...		-	National Cancer Center, Korea
Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)	NCT04464122	Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	Somatostatin an...	18 Years - 80 Years	University of Roma La Sapienza
Prognostic Markers of Gynecologic Cancers	NCT00290459	Gynecologic Dis... Gynecologic Can...		18 Years -	University of Louisville
Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells	NCT01286883	Colorectal Canc...		18 Years -	Milton S. Hershey Medical Center
Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)	NCT04464122	Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	Somatostatin an...	18 Years - 80 Years	University of Roma La Sapienza
Role of Immunoscore® in Stage II-III Colorectal Cancer	NCT05422547	Colon Adenocarc...	Immunoscore Col...	-	D'Or Institute for Research and Education

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