Effect of Gene Polymorphisms on the Pathogenesis of Cancer Cachexia

NCT04131478 | Unknown DMC

• 1 other identifier: PT (2387)
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Cachexia not only directly increases the morbidity and mortality, it also aggravates the side effects of chemotherapy and reduces the overall quality of life that is often considered the major and direct cause of morbidity of a large proportion (\>40%) of cancer patients. Individuals with upper gastrointestinal tumors have the highest rate of developing cachexia associated complications. Chemical and physical signals render an environment conducive for disuse and untenable for proper muscle function leading to wasting. Till now, several functional single-nucleotide polymorphisms (SNPs) within TNF-α gene have been identified and described as cancer related genetic alterations.

Conditions

Cancer Cachexia

Keywords

cancer cachexia; TNF alfa; pharmacogenetics; mi-RNA

Outcome Measures

Primary Outcomes (1)

• TNF-α -1031T/C and 308 G/A

  To detect the incidence of tumor necrosis factor (TNF-α -1031T/C and 308 G/A) gene polymorphism in the Egyptian cancer patients with local/advanced or metastatic cancer and investigation of TNF-α -1031T/C and 308 G/A as a cachexia risk factor.

  6 months

Secondary Outcomes (1)

• Biochemical markers

  6 months

Study Arms (2)

Cases

Cachectic lung, pancreas, or colon cancer patients.

Genetic: Pharmacogenetic testing

Control

Non- cachectic lung, pancreas, or colon cancer patients.

Genetic: Pharmacogenetic testing

Interventions

Pharmacogenetic testing GENETIC

Pharmacogenetic testing for TNF alfa

Cases; Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cachectic and non- cachectic cancer patients

You may qualify if:

• The duration was set based on standard period of first line chemotherapy
• Age of 18 years to 80 years
• Written informed consent of the subject to participate in the study

You may not qualify if:

• Planned to have surgical procedures at the time of recruitment
• Underwent surgery during the study or in the month prior to the study and did not have chemotherapy scheduled postsurgery
• Had any comorbidities that could affect the interpretation of study findings (eg, HIV, AIDS, Alzheimer's disease, movement disorder, acute myocardial infarction within last 3 months, hepatitis)
• Had open burn sites or infected wounds
• Were diagnosed with esophageal cancer with a swallowing difficulty in mechanical nature
• Had an uncorrected, mechanical digestive obstruction
• Pregnant or nursing women
• Disorders associated with change in micro RNA (miR-155) level (Rheumatic Arthritis, Osteoarthritis, Atopic Eczema, Down Syndrome, Breast cancer, Endometrioid adenocarcinoma, AML, CLL, PC thyroid tumors)
• Inflammatory and autoimmune diseases (Multiple Sclerosis, Psoriasis and Systemic Lupus Erythematous)

Sponsors & Collaborators

• Cairo University: lead
• Misr International University: collaborator
• Ain Shams University: collaborator

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11314, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A heparinized blood sample (5 mls) will be withdrawn from all patients, and divided in 2 aliquots. One aliquot will be spared for DNA and the other for RNA extraction.

MeSH Terms

Interventions

Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Central Study Contacts

Rana M. Yehia, MSc

CONTACT

+201006666652; rana.magdy@miuegypt.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacology

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: June 20, 2019
• Primary Completion: June 20, 2020
• Study Completion: January 1, 2021
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)