Neoplasms

Digestive System Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Stomach Neoplasms

Congenital Abnormalities

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

taking blood samples from apparently healthy people

taking blood samples and measure telomeric abnormalities

taking blood samples

eman mosaad, prof.dr

fatma magdy zidan, residant

Colorectal carcinoma is a heterogeneous disease that is caused by the interaction of genetic and environmental factors. colorectal carcinoma encompasses a complex disease with different molecular pathways and biological characteristics arising from a multi-step process that implicates several genetic and epigenetic events . The multi-step genetic model involves the loss of function of tumor suppressor genes, such as adenomatous polyposis coli (APC), Telomeres could be a promising marker due to the fact that their lengths change in the colorectal polyp-carcinoma sequence . Moreover, telomere length (TL) is altered in blood cells in patients with colorectal carcinoma

* These findings could suggest that changes in TL may take place before the development of the tumor .

The two main forms of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are characterized by chronic intestinal inflammation and risk of progression to colon cancer. One proposed cause of the latter characteristic is chromosome instability, since the rearrangement of genetic material can lead to activation of oncogenes, loss of tumor suppressor genes and other changes that lead to uncontrolled cell growth. Chromosome instability is particularly associated with UC and has been observed in colon epithelial cells and peripheral blood mononuclear cell. Since genomic instability in peripheral blood mononuclear cells (PBMCs) has been used as a biomarker for global cancer risk in a number of diseases, the latter observation suggests the possibility of a chromosome instability syndrome in UC that could affect all tissues. One possible cause of chromosome instability is telomere dysfunction .

Human chromosomes are capped and stabilized by telomeres, which not only protect them from damage but also have a role in regulating cellular senescence. After reaching a critical length, telomeres experience a double DNA change and cells will eventually enter senescence (replication) or cell death . Telomere length and telomere shortening have been long hypothesized to be a biological marker of aging at the cellular level and a potential mechanism of carcinogenesis. Genomic instability is a critical factor in the initiation and progression of human cancers. One mechanism that underlies genomic instability is loss of telomere function .

fluorescent in situ hybridization is a molecular diagnostic technique that utilizes labeled DNA probes to detect or confirm gene or chromosome abnormalities. fluorescent in situ hybridization is often utilized for both research and diagnosis of hematological malignancies and solid tumors. Conceptually, fluorescent in situ hybridization is a very straightforward technique whereby a DNA probe is hybridized to its complementary sequence on chromosomal preparations previously fixed on microscope slides . fluorescent in situ hybridization is able to detect cells that have chromosomal abnormalities consistent with neoplasia .

There has been a surge of published studies which assessed the association between telomere length and development of colorectal carcinoma. Thus, a meta-analysis addressing colorectal carcinoma and telomere length would be a useful addition to the current information in this area.

Telomeric Abnormalities in Colorectal Diseases by Fluorescent in Situ Hybridization Technique

Telomeric Abnormalities in Benign and Malignant Colorectal Diseases by Fluorescent in Situ Hybridization Technique

measure percentage of telomeric abnormalities in benign and malignant colorectal diseases

Assiut University

principle investigator

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Eniluracil

Antimetabolites

Fixed dose of PCS6422 combined with various doses of Capecitabine administered in 14 day cycles

PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer. Capecitabine is a commonly used oral fluoropyrimidine.

PCS6422 and capecitabine

Mary Nyberg

Debbie Vidlak

Jean Grem, MD

Ahsan Khan

Patrick Boland, MD

Mohammed Ghalib

Eric Feldman, MD

Celestine Slapnicker

Amit Mahipal, MD

Sharon Goldberg

Alexander Spira, MD

Sian Bigora, Pharm. D

This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.

A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors

A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 With Escalating Doses of Capecitabine Administered Orally to Patients With Advanced, Refractory Gastrointestinal Tract Tumors

Frequency, duration, and severity of DLTs and adverse events (AEs)

To evaluate the Maximum Plasma Concentration (Cmax) of capecitabine

To evaluate the Maximum Plasma Concentration (Cmax) of PCS6422

Frequency, duration and severity of AESIs

Processa Pharmaceuticals

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antirheumatic Agents

Cyclophosphamide

Vaccines

Immunologic Factors

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Drug:Cyclophosphamide

Biological/Vaccine:Tumor Specific Antigen-loaded Dendritic Cells

Subjects will be given subcutaneous injection of 5.0x10\^6-1.0x10\^7 TSA-DC on week 1,3,5,11,17,23,35,47.

Tumor Specific Antigen-loaded Dendritic Cells

300 mg/m2 by vein before the first cell infusion.

Yu Chen, Doctor

ZengQing Guo, Professor

The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC vaccine.

20 gastrointestinal solid tumor subjects failed from at least one systemic therapy will be enrolled into the trial .Subjects will be given subcutaneous injection of 5.0x10\^6-1.0x10\^7 TSA-DC on week 1, 3, 5, 11,17,23,35,47. Before the first cell infusion, the subjects should undergo a non-myeloablative chemotherapy regimen of Cyclophosphamide 300mg/m2 iv. Radiologic tumor assessment will be repeated every 8 weeks during treatment, until time of progression. Treatment will continue until disease progression, intolerance of toxic , withdrawal from the study, study completion, or study termination.

TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor

Study of DC Vaccine Loaded Tumor Specific Antigen in Treating Patients With Gastrointestinal Solid Tumor

All the local or systemic reactions, adverse events and serious adverse events that occurred between the first and the second TSA-DC administration.

Percentage of cases whose tumor shrinks to a certain extent and remains for a certain period of time.

All local or systemic reactions, adverse events and serious adverse events that occurred from entering the trial until 30 days after the last treatment;

Percentage of cases with no progression (CR + PR + SD) in 6 months after initiation of treatment;

The time from the first tumor evaluation of remission(CR + PR ) till the first assessment of PD or the end the study.

The time from entering the trial till the subject has been diagnosed with progression of disease or died.

Percentage of cases with 12 months survival after initiation of treatment in all the subjects;

Evaluated by the questionnaire of life improvement quality collected from the screening to treatment periods.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Telomeric Abnormalities in Colorectal Diseases by Fluorescent in Situ Hybridization Technique	NCT03208777	Tumor Gastric	taking blood sa...	18 Years -	Assiut University
A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors	NCT04861987	Advanced Cancer Refractory Canc... Tumor Gastric	PCS6422 and cap...	18 Years -	Processa Pharmaceuticals
TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor	NCT03185429	Tumor Gastric Tumor, Colorect...	Tumor Specific ... Cyclophosphamid...	18 Years - 75 Years	BGI, China
TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor	NCT03185429	Tumor Gastric Tumor, Colorect...	Tumor Specific ... Cyclophosphamid...	18 Years - 75 Years	BGI, China
TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor	NCT03185429	Tumor Gastric Tumor, Colorect...	Tumor Specific ... Cyclophosphamid...	18 Years - 75 Years	BGI, China

Spots Global Cancer Trial Database for tumor gastric