Breast CancerNCT04611308
The Role of C1q Tumor Necrosis Factor-related Protein 6 in Breast Cancer
An observational study of Breast Cancer, run by Assiut University.
Trial summary
Globally, breast cancer is one of the most prevalent cancers in women and is the second leading cause of cancer death , representing 15% of worldwide deaths per year . In Egypt, it accounts for 32 % of cancer in women with a high mortality rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- C1q tumor necrosis factor-related protein 6 levels
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Oct 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Approximately 102 cases.
Who may be able to join
- Age: 18 years and older.
- Newly diagnosed patients with histopathological confirmation of the diagnosis of breast cancer at any stage.
Who cannot join
- Patients with a prior history of other cancers.
- Patients with more than one cancer.
- Patients treated with chemotherapy or radiotherapy before initial samples collection.
- Pregnant women.
- Patients with unqualified or insufficient data.
About this study
Official title: The Role of C1q Tumor Necrosis Factor-related Protein 6 (CTRP6) in Breast Cancer
Globally, breast cancer is one of the most prevalent cancers in women and is the second leading cause of cancer death , representing 15% of worldwide deaths per year . In Egypt, it accounts for 32 % of cancer in women with a high mortality rate.
Read the detailed description
Globally, breast cancer is one of the most prevalent cancers in women and is the second leading cause of cancer death , representing 15% of worldwide deaths per year. In Egypt, it accounts for 32 % of cancer in women with a high mortality rate.
The etiology of breast cancer is multifactorial in which multiple epigenetic and genetic variations affect its incidence and prognosis . Although diagnostic methods and therapeutic strategies for breast cancer have been improved in past decades, long-term survival of breast cancer patients still remains poor due to high proliferation, metastasis and post-surgical recurrence rate.
Therefore, it is critical to develop more effective screening methods that can detect BC at an early stage and novel therapeutic targets for better treatment. This may be achieved by understanding the molecular mechanisms underlying the initiation and progression of this malignancy.
Complement C1q tumor necrosis factor-related protein (CTRPs) are a protein family of adiponectin paralogs which contains fifteen members, CTRP1- CTRP15. This super family are involved in several biological processes, including metabolism, immunity, inflammation, apoptosis and cell differentiation (15, 16). Accumulating evidence correlates CTRP family members with carcinogenesis and signaling pathways associated with cancer development, progression and metastasis.
C1q tumor necrosis factor-related protein 6 (CTRP6) or (C1qTNF6) is a member of CTRPs family. It contains four domains including signal peptide, short N-terminal variable region, collagen domain and C-terminal C1q domain. It is expressed mainly in placenta, heart, uterus and adipose tissue.
CTRP6 is involved in multiple physiological processes, such as regulating cell proliferation and differentiation. It also mediates fatty acid oxidation, adipogenesis and insulin sensitivity, attenuates cell fibrosis and displays anti-inflammatory properties.
Although recent studies have revealed that adiponectin has an inhibitory role in carcinogenesis, the role of CTRP6 in carcinogenesis remains unclear. CTRP6 was initially found to be overexpressed and possibly contributes to tumor angiogenesis in many hepatocellular carcinomas. Moreover, recent research indicates that CTRP6 is correlated with gastric cancer progression by mediating proliferation, migration and apoptosis, which reveals a similar pattern in lung adenocarcinoma.
However, tumor suppressor functions of CTRP6 were also successively reported. CTRP6 was found to have inhibitory effect on the proliferation and migration of ovarian cancer cells. Moreover, CTRP6 significantly suppressed the growth and invasion activity of the oral squamous cell carcinoma cells.
The role CTRP6 plays in breast cancer is yet unknown. The present study will investigate the level of CTRP6 in BC specimens. Furthermore, the pathological functions of CTRP6 in BC, including cell growth, proliferation, migration, and effect on inflammation and angiogenesis will be studied in breast cancer cells.
- Conditions
- Breast Cancer
- Being tested
- C1q tumor necrosis factor-related protein 6 levels
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1q tumor necrosis factor-related protein 6 levelsOther
C1q tumor necrosis factor-related protein 6 is a tumor marker
| Study group | Role | What they receive |
|---|---|---|
| cases | Not described Receives: Other: C1q tumor necrosis factor-related protein 6 levels | |
| controls | Not described Receives: Other: C1q tumor necrosis factor-related protein 6 levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the CTRP6 levels in breast cancer.
Measured: 1 October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Farouk Hamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611308
- Sponsor's protocol ID
- CTRP6 in Breast Cancer
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of C1q Tumor Necrosis Factor-related Protein 6 (CTRP6) in Breast Cancer
- ClinicalTrials.gov ID
- NCT04611308
- Acronym / sponsor ID
- CTRP6 in Breast Cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 2 Nov 2020 (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.
Globally, breast cancer is one of the most prevalent cancers in women and is the second leading cause of cancer death , representing 15% of worldwide deaths per year . In Egypt, it accounts for 32 % of cancer in women with a high mortality rate.
Detailed description
Globally, breast cancer is one of the most prevalent cancers in women and is the second leading cause of cancer death , representing 15% of worldwide deaths per year. In Egypt, it accounts for 32 % of cancer in women with a high mortality rate.
The etiology of breast cancer is multifactorial in which multiple epigenetic and genetic variations affect its incidence and prognosis . Although diagnostic methods and therapeutic strategies for breast cancer have been improved in past decades, long-term survival of breast cancer patients still remains poor due to high proliferation, metastasis and post-surgical recurrence rate.
Therefore, it is critical to develop more effective screening methods that can detect BC at an early stage and novel therapeutic targets for better treatment. This may be achieved by understanding the molecular mechanisms underlying the initiation and progression of this malignancy.
Complement C1q tumor necrosis factor-related protein (CTRPs) are a protein family of adiponectin paralogs which contains fifteen members, CTRP1- CTRP15. This super family are involved in several biological processes, including metabolism, immunity, inflammation, apoptosis and cell differentiation (15, 16). Accumulating evidence correlates CTRP family members with carcinogenesis and signaling pathways associated with cancer development, progression and metastasis.
C1q tumor necrosis factor-related protein 6 (CTRP6) or (C1qTNF6) is a member of CTRPs family. It contains four domains including signal peptide, short N-terminal variable region, collagen domain and C-terminal C1q domain. It is expressed mainly in placenta, heart, uterus and adipose tissue.
CTRP6 is involved in multiple physiological processes, such as regulating cell proliferation and differentiation. It also mediates fatty acid oxidation, adipogenesis and insulin sensitivity, attenuates cell fibrosis and displays anti-inflammatory properties.
Although recent studies have revealed that adiponectin has an inhibitory role in carcinogenesis, the role of CTRP6 in carcinogenesis remains unclear. CTRP6 was initially found to be overexpressed and possibly contributes to tumor angiogenesis in many hepatocellular carcinomas. Moreover, recent research indicates that CTRP6 is correlated with gastric cancer progression by mediating proliferation, migration and apoptosis, which reveals a similar pattern in lung adenocarcinoma.
However, tumor suppressor functions of CTRP6 were also successively reported. CTRP6 was found to have inhibitory effect on the proliferation and migration of ovarian cancer cells. Moreover, CTRP6 significantly suppressed the growth and invasion activity of the oral squamous cell carcinoma cells.
The role CTRP6 plays in breast cancer is yet unknown. The present study will investigate the level of CTRP6 in BC specimens. Furthermore, the pathological functions of CTRP6 in BC, including cell growth, proliferation, migration, and effect on inflammation and angiogenesis will be studied in breast cancer cells.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: C1q tumor necrosis factor-related protein 6 levels |
| controls | – | Other: C1q tumor necrosis factor-related protein 6 levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Approximately 102 cases.
Key inclusion criteria (2 listed)
- Age: 18 years and older.
- Newly diagnosed patients with histopathological confirmation of the diagnosis of breast cancer at any stage.
Key exclusion criteria (5 listed)
- Patients with a prior history of other cancers.
- Patients with more than one cancer.
- Patients treated with chemotherapy or radiotherapy before initial samples collection.
- Pregnant women.
- Patients with unqualified or insufficient data.
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 |
|---|---|---|
| C1q tumor necrosis factor-related protein 6 levelsC1q tumor necrosis factor-related protein 6 is a tumor marker | Other | cases, controls |
Primary outcome
To investigate the CTRP6 levels in breast cancer.
Time frame: 1 October 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
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 2 inclusion and 5 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 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the CTRP6 levels in breast cancer. (time frame: 1 October 2021). 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 2 Nov 2020.