Cervical CancerXac03NCT02875990
Characterization of Immunosuppressive Signing of Cervical Cancer
A study testing Blood sample in people with Cervical Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are associated with immunosuppression and lack of T cell response Such mechanisms would promote progression to cancer and progression of it . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Sep 2024
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The women presenting for initial therapeutic management of cervical cancer
- Elderly patients over 18 years
- Patients beneficiary of a social security scheme
- Pregnant women can not participate in this study
- Women known to be HIV positive will not participate in this study
Who cannot join
- Patients with a recurrence of a treaty cervical cancer
- Patients with a history of pelvic radiotherapy
- Patients unable to receive informed about the progress and objectives of the study
- Patients not receiving a social security scheme
- Patients who have not signed informed consent
- Immunocompromised patients and pregnant women
Trial locations and contacts
1 site in 1 country.
Xavier CARCOPINO, PU-PH contact
France1 site
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Xavier CARCOPINO, PU-PH, xavier.carcopino@ap-hm.fr
Urielle DESALBRES, Director, 04.91.38.27.47, drci@ap-hm.fr
About this study
Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are associated with immunosuppression and lack of T cell response Such mechanisms would promote progression to cancer and progression of it . Various factors such as an increase of regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms. At this stage of knowledge, a better characterization of local and systemic immunosuppressive signing of cervical cancer is needed. The results should have a significant medical impact for the identification of new prognostic markers and new therapeutic targets for the treatment of patients with cervical cancer.
The aim of this research project is to define the signing of immunosuppressive cancer cervix and analyze the different mechanisms involved in this immunosuppression.
- Conditions
- Cervical Cancer
- Being tested
- Blood sample
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| patients with invasive cervical cancer | Experimental | Blood sample Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lack of tumor emboli histological analysis
Patients with good prognosis of cervical cancer
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875990
- Sponsor's protocol ID
- 2014-03
- Other IDs
- 2015-A00699-40
- Acronym
- Xac03
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immunosuppressive Signing of Cervical Cancer
- ClinicalTrials.gov ID
- NCT02875990
- Acronym / sponsor ID
- Xac03 / 2014-03
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 23 Aug 2016 (estimated)
- 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.
Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are associated with immunosuppression and lack of T cell response Such mechanisms would promote progression to cancer and progression of it . Various factors such as an increase of regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms. At this stage of knowledge, a better characterization of local and systemic immunosuppressive signing of cervical cancer is needed. The results should have a significant medical impact for the identification of new prognostic markers and new therapeutic targets for the treatment of patients with cervical cancer.
The aim of this research project is to define the signing of immunosuppressive cancer cervix and analyze the different mechanisms involved in this immunosuppression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with invasive cervical cancer | Experimental | Biological: Blood sampleBlood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The women presenting for initial therapeutic management of cervical cancer
- Elderly patients over 18 years
- Patients beneficiary of a social security scheme
- Pregnant women can not participate in this study
- Women known to be HIV positive will not participate in this study
Key exclusion criteria (6 listed)
- Patients with a recurrence of a treaty cervical cancer
- Patients with a history of pelvic radiotherapy
- Patients unable to receive informed about the progress and objectives of the study
- Patients not receiving a social security scheme
- Patients who have not signed informed consent
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 |
|---|---|---|
| Blood sample | Biological | patients with invasive cervical cancer |
Primary outcome
Lack of tumor emboli histological analysis
Time frame: 60 months
Patients with good prognosis of cervical cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- 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.
Xavier CARCOPINO, PU-PH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Cervical Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 5 inclusion and 6 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 23 Aug 2016. 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 France. 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 Xavier CARCOPINO, PU-PH (xavier.carcopino@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lack of tumor emboli histological analysis (time frame: 60 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 23 Aug 2016.