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Cancer of CervixEPIcolNCT06147960

Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on Recurrence Rate in Cervical Cancer

An observational study of Cancer of Cervix and Apoptosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Overexpression of inhibitors of apoptosis proteins (IAPs) in patients treated for locally advanced cervical cancer with exclusive radio-chemotherapy may have a prognostic role on the local recurrence rate at 24 months. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer of Cervix, Apoptosis
What is being tested?
Immunohistochemistry
How many people
180 participants
Where
1 siteFrance
Study dates
26 Sep 2024to Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Adult, Older adult

Study population: The study population is made up of women treated with the exclusive radio-chemotherapy combination for locally advanced cervical carcinoma, managed at the Montpellier Institute of Cancer and Montpellier and Nîmes University Hospitals.

Who may be able to join

  • Patients treated with the exclusive radio-chemotherapy combination for locally advanced cervical carcinoma (stage Ib-IVb according to FIGO classification).
  • Patients aged ≥ 18 years.
  • Patients with a minimum of 2 years post-treatment follow-up.
  • Patients for whom the initial biopsy specimen (before treatment) is available.
  • Patients who have not indicated that they do not wish to participate in the study.
  • Patients affiliated to or benefiting from a health insurance scheme.

Who cannot join

  • Patients under court protection, guardianship or curatorship.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Frédéric FITENI, Dr. contact

+334.34.03.46.69

frederic.fiteni@chu-nimes.fr

Anissa MEGZARI contact

+33466684236

drc@chu-nimes.fr

France1 site, 1 recruiting
  • CHU de Nîmes

    Nîmes, Gard, 30029

    Anissa MEGZARI, + 33 4.66.68.30.09, drc@chu-nimes.fr

    Frédéric FITENI, PU-PH

    Recruiting

Other trials in France

About this study

Official title: Evaluation of the Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on the 24-month Recurrence Rate in Locally Advanced Cervical Cancer

Overexpression of inhibitors of apoptosis proteins (IAPs) in patients treated for locally advanced cervical cancer with exclusive radio-chemotherapy may have a prognostic role on the local recurrence rate at 24 months.

Read the detailed description

Cervical cancer remains one of the most common cancers in women in terms of both incidence and mortality. Human Papilloma Virus carriage is a necessary condition for the development of these cancers but is not the only factor responsible for malignant transformation. Numerous molecular alterations come into play in the development of these tumours, involving the activation of oncogenes or the inactivation of tumour suppressor genes. Treatment of locally-advanced cancer is based on radiotherapy or a combination of radiotherapy and chemotherapy. Responses to anti-neoplastic treatments remain very heterogeneous from one woman to another. Predicting the response to these treatments would make it possible to envisage early therapeutic alternatives for patients identified as not very sensitive to standard treatments. IAPs (inhibitors of apoptosis proteins), which include XIAP, cIAP1 and cIAP2, are proteins involved in many cancers and capable of downregulating tumour cell apoptosis. It seems justified to investigate the role of these IAPs in resisting apoptosis-inducing anti-neoplastic treatments such as chemotherapy or radiotherapy. The aim of our study is to assess the prognostic role of overexpression of IAPs in locally advanced cervical cancer treated exclusively with radio-chemotherapy. This research seems all the more important as IAP-inhibiting molecules are currently being studied in other types of cancer (ear, nose and throat cancers) and appear to have a very encouraging radiosensitising effect. The hypothesis is that overexpression of IAPs in patients treated for locally advanced cervical cancer with exclusive radio-chemotherapy has a prognostic role on the local recurrence rate at 24 months.

Being tested
Immunohistochemistry
Keywords
Apoptosis inhibiting proteins, Cervical cancer, Apoptosis
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.

  • ImmunohistochemistryDiagnostic test

    Blocks containing formalin-fixed, paraffin-embedded (FFPE) biopsies will be used to analyse the expression of XIAP, cIAP1 and cIAP2 proteins by immunohistochemistry. The antibodies will be selected on the basis of the literature and their validation for this technology (Schnoell et al. 2020). The immunohistochemical techniques will be performed on an automated immunolabelling machine (DakoLink®) after antigen demasking. The specific binding of primary antibodies will be revealed by the application of Flex reagent (Dako Agilent), a dextran polymer coupled on the one hand to anti-mouse and anti-rabbit immunoglobulins, and on the other hand to a large number of horseradish peroxidase (HRP) molecules. 3,3'-Diaminobenzidine (DAB) will be used as a substrate for this enzyme to highlight the specific expression of the biomarker. The use of an automated system will ensure the reproducibility of inter-sample labelling.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prognostic role of overexpression of XIAP on the rate of local recurrence in patients treated for locally advanced cervical cancer.

    Overexpression of the Inhibitor of Apoptosis Proteins XIAP will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer. The H-score for XIAP will be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

    Measured: Baseline

  2. Prognostic role of overexpression of XIAP on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer.

    Overexpression of the Inhibitor of Apoptosis Proteins XIAP will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer. The H-score for XIAP will be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

    Measured: 24 months

  3. Prognostic role of overexpression of cIAP1 on the rate of local recurrence in patients treated for locally advanced cervical cancer.

    Overexpression of Inhibitors of the Apoptosis Protein cIAP1 will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer.The H-score for cIAP1 be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

    Measured: Baseline

  4. Prognostic role of overexpression of cIAP1 on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer.

    Overexpression of the Inhibitor of Apoptosis Protein cIAP1 will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer.The H-score for cIAP1 be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

    Measured: 24 months

  5. Prognostic role of overexpression of cIAP2 on the rate of local recurrence in patients treated for locally advanced cervical cancer.

    Overexpression of the Inhibitor of Apoptosis Protein cIAP2 will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer.The H-score for cIAP2 be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

    Measured: Baseline

  6. Prognostic role of overexpression of cIAP2 on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer.

    Overexpression of the Inhibitor of Apoptosis Protein cIAP2 will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer. The H-score for cIAP1 be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

    Measured: 24 months

  7. Local recurrence of cervical cancer

    Local recurrence of cervical cancer at 24 months follow-up according to RECIST v1.1 criteria: Yes/No.

    RECIST 1.1 is a standard way to measure the response of a tumor to treatment in which Complete Response = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. Partial Response = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer.

Secondary outcomes (14)
  1. A. Overall survival in patients treated for locally advanced cervical cancer at baseline.

    Death will be recorded as YES/NO

    Measured: Baseline

  2. A. Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer.

    Death will be recorded as YES/NO

    Measured: 24 months

  3. B. Progression-free survival in patients treated for locally advanced cervical cancer.

    The time from diagnosis to death from any cause will be recorded in months and days.

    Measured: Baseline

  4. B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer.

    The time from diagnosis to death from any cause will be recorded in months and days.

    Measured: 24 months

  5. B. Progression-free survival in patients treated for locally advanced cervical cancer: RECIST criteria

    The time between diagnosis and progression according to v1.1 of the RECIST criteria or death from any cause will be recorded in days.

    RECIST 1.1 is a standard way to measure the response of a tumor to treatment in which Complete Response = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. Partial Response = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Baseline

  6. B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: RECIST criteria

    The time between diagnosis and progression according to v1.1 of the RECIST criteria or death from any cause will be recorded in days.

    RECIST 1.1 is a standard way to measure the response of a tumor to treatment in which Complete Response = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. Partial Response = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: 24 months

  7. B. Progression-free survival in patients treated for locally advanced cervical cancer. H-score

    The histochemical scoring assessment (H-SCORE) will be recorded on a scale of 0-300

    Measured: Baseline

  8. B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: H-score

    The histochemical scoring assessment (H-SCORE) will be recorded on a scale of 0-300

    Measured: 24 months

  9. C. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and Programmed Death - Ligand 1 expression.

    The expression level of XIAP and the expression level of PD-L1 in biopsies will be measured by immunohistochemistry.

    Measured: Baseline

  10. C. Correlation between the Inhibitor of Apoptosis Protein cIAP1 expression and Programmed Death - Ligand 1 expression.

    The expression level of cIAP1 and the expression level of PD-L1 in biopsies will be measured by immunohistochemistry.

    Measured: Baseline

  11. C. Correlation between the Inhibitor of Apoptosis Protein cIAP2 expression and Programmed Death - Ligand 1 expression.

    The expression levels of cIAP2 and expression level of PD-L1 in biopsies will be measured by immunohistochemistry.

    Measured: Baseline

  12. D. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and lymphocytic tumour infiltration (LTI).

    The expression level of XIAP and the level of lymphocytic tumour infiltration will be measured as % in biopsies.

    Measured: Baseline

  13. D. Correlation between the Inhibitor of Apoptosis Protein cIAP1 expression and lymphocytic tumour infiltration (LTI).

    The expression level of cIAP1 and the level of lymphocytic tumour infiltration will be measured as % in biopsies.

    Measured: Baseline

  14. D. Correlation between the Inhibitor of Apoptosis Protein cIAP2 expression and lymphocytic tumour infiltration (LTI).

    The expression level of cIAP2 and the level of lymphocytic tumour infiltration will be measured as % in biopsies.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2023
  2. Study start26 Sep 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06147960
Sponsor's protocol ID
NIMAO/2023-1/FF-01
Acronym
EPIcol
Status last verified
Jun 2026
First submitted
13 Nov 2023
Last updated
22 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer of Cervix and Apoptosis, run by Centre Hospitalier Universitaire de Nīmes 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frédéric FITENI, Dr. (+334.34.03.46.69, frederic.fiteni@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prognostic role of overexpression of XIAP on the rate of local recurrence in patients treated for locally advanced cervical cancer. (time frame: Baseline). The study lists 7 primary outcomes in all. 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 22 Jun 2026.

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