Cancer CachexiaNCT04131478
Effect of Gene Polymorphisms on the Pathogenesis of Cancer Cachexia
An observational study of Cancer Cachexia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- Pharmacogenetic testing
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2019to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cachectic and non- cachectic cancer patients
Who may be able to join
- Patients with medical diagnosis of cancer (eg, lung, pancreas, gastric, biliary, small intestine, or colorectal) Locally, advanced or metastatic cancer scheduled for the first line cytotoxic chemotherapy were eligible for inclusion. Patients who were starting or continuing chemotherapy at the time of screening for participants
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo, 11314
Dr. Amr Shafik, PhD
About this study
Official title: Relationship Between TNF Alpha Gene Polymorphisms and the Pathogenesis of Cachexia in Cancer Patients Treated With Chemotherapy
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.
Read the detailed description
Cachexia is a devastating syndrome that is observed in the majority of end stage cancer patients. Primary symptoms of cancer cachexia comprise of progressive loss in weight and exhaustion of host skeletal muscle tissue as well as adipose tissue reserves.
Cancer cachexia is defined as a multifactorial syndrome, characterized by anorexia as well as diminished body weight, loss of skeletal muscle, and atrophy of adipose tissue (Fearon et al., 2011). Specifically, weight loss of more than 5% over 6 months span in previously healthy individuals or more than 2% in subjects with depletion of current body weight (BMI less than 20 kg/m2) or in individuals with reduced appendicular muscle index (males less than 7.26 kg/m2 and females less than 5.45 kg/m2) constitute the diagnosis of cancer cachexia.
Among potential mechanisms involved in the development of cachexia, the primary initial process is probably the systemic inflammatory response followed by increased production of pro-inflammatory cytokines, such as TNF-α. Multiple biological activities of TNF-α were found in numerous physiological states, including the regulation of cell differentiation, proliferation, apoptosis and metabolism .
- Conditions
- Cancer Cachexia
- Being tested
- Pharmacogenetic testing
- Keywords
- cancer cachexia, TNF alfa, pharmacogenetics, mi-RNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic testingGenetic
Pharmacogenetic testing for TNF alfa
| Study group | Role | What they receive |
|---|---|---|
| Cases | Cachectic lung, pancreas, or colon cancer patients. Receives: Genetic: Pharmacogenetic testing | |
| Control | Non- cachectic lung, pancreas, or colon cancer patients. Receives: Genetic: Pharmacogenetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Biochemical markers
SOCS1, TAB2 and FOXP3
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start20 Jun 2019
- Primary completion20 Jun 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University, Ain Shams University
- Responsible party
- Principal investigator, Samira Saleh Mostafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131478
- Sponsor's protocol ID
- PT (2387)
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between TNF Alpha Gene Polymorphisms and the Pathogenesis of Cachexia in Cancer Patients Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT04131478
- Acronym / sponsor ID
- PT (2387)
- Conditions
- Cancer Cachexia
- Keywords
- cancer cachexia, TNF alfa, pharmacogenetics, mi-RNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Misr International University, Ain Shams University
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Jun 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cachexia is a devastating syndrome that is observed in the majority of end stage cancer patients. Primary symptoms of cancer cachexia comprise of progressive loss in weight and exhaustion of host skeletal muscle tissue as well as adipose tissue reserves.
Cancer cachexia is defined as a multifactorial syndrome, characterized by anorexia as well as diminished body weight, loss of skeletal muscle, and atrophy of adipose tissue (Fearon et al., 2011). Specifically, weight loss of more than 5% over 6 months span in previously healthy individuals or more than 2% in subjects with depletion of current body weight (BMI less than 20 kg/m2) or in individuals with reduced appendicular muscle index (males less than 7.26 kg/m2 and females less than 5.45 kg/m2) constitute the diagnosis of cancer cachexia.
Among potential mechanisms involved in the development of cachexia, the primary initial process is probably the systemic inflammatory response followed by increased production of pro-inflammatory cytokines, such as TNF-α. Multiple biological activities of TNF-α were found in numerous physiological states, including the regulation of cell differentiation, proliferation, apoptosis and metabolism .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Genetic: Pharmacogenetic testingCachectic lung, pancreas, or colon cancer patients. |
| Control | – | Genetic: Pharmacogenetic testingNon- cachectic lung, pancreas, or colon cancer patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cachectic and non- cachectic cancer patients
Key inclusion criteria (4 listed)
- Patients with medical diagnosis of cancer (eg, lung, pancreas, gastric, biliary, small intestine, or colorectal) Locally, advanced or metastatic cancer scheduled for the first line cytotoxic chemotherapy were eligible for inclusion. Patients who were starting or continuing chemotherapy at the time of screening for participants
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic testingPharmacogenetic testing for TNF alfa | Genetic | Cases, Control |
Primary outcome
TNF-α -1031T/C and 308 G/A
Time frame: 6 months
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.
1 secondary outcome
Biochemical markers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Cachexia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana M. Yehia, MSc (+201006666652, rana.magdy@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNF-α -1031T/C and 308 G/A (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.