Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in TunisiaBIOPEACENCT05871788

Biomarkers in Patients With Metastatic Breast Cancer

An observational study of Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in Tunisia, run by Tunisian Association for Immuno-oncology Research.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

In order to allow Tunisian patients with breast cancer to access immunotherapies, and innovative treatments to extend life expectancy of patients with breast cancer with a poor prognosis, it is important to study the epidemiological profile of Tunisian cancers breast, in terms of PD-L1 expression, tumor mutational… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in Tunisia
What is being tested?: identify biomarkers
How many people: 1,600 participants
Where: No sites listed yet
Study dates: Jun 2023to Dec 2027
How long will I take part?: 1 Year
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
No healthy volunteers
Adult, Older adult

Study population: Patients with metastatic or locally advanced breast cancer in Tunis, Tunisia.

Who may be able to join

Age ≥ 18 years old.
Signed informed consent
Histological evidence of breast carcinoma.
Locally advanced (stage III inoperable) or metastatic (stage IV) carcinoma, the metastases of which have been diagnosed straight away or after adjuvant or neoadjuvant treatment.
No treatment for metastatic disease.
Metastatic disease: histological evidence of metastasis
Patients who will receive systemic treatment (chemotherapy, targeted therapy, hormone therapy)
Life expectancy greater than 3 months

Who cannot join

Non-epithelial breast cancer
Non-biopsiable metastases
Patients who have received before systemic treatment for metastatic disease (chemotherapy, targeted therapy, hormone therapy)
Patients with a contraindication to chemotherapy, and / or hormone therapy, and
/ or targeted therapy.
Foreign patients

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Monia Malek, MD contact

00216 28 101 505

monia.malek@gmail.com

About this study

It is also important to study other inflammatory and tumor biomarkers which would have a prognostic or even therapeutic value:

serum dosage of LDH (lactate dehydrogenase)
IL-6 (interleukin 6)
CRP (C-reactive protein)
absolute count of lymphocytes (CLA) and eosinophils
quantification of circulating tumor DNA before treatment and under treatment. The primary objective id to identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma before and during the systemic treatment.

Read the detailed description

Procedure:

Verification of the inclusion / non-inclusion criteria
Signing the consent form
Surgical, Medical and family history, ongoing treatments
Clinical Examination1
Radiological examinations 2
TNM Classification (Appendix 3)
Standard biochemical assessment 3
Inflammatory assessment (CRP, LDH, IL6)
Hematological assessment (NFS, platelets)
Tumor markers (ACE, CA15-3)
Histological and molecular examination 4:

Expression PD-L1 by IHC (Immuno-Histochemistry)
TILs by IHC
- MSI status: MMR * proteins (Mismatch Repair Protein) (Appendix 4) by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1>1%
Score HRD : by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1>1%
TMB mutational burden by next generation sequencing "Next Generation Sequencing" (NGS) via TruSight™ Oncology 500 Kit (Illumina) if PD-L1>1%
tDNA by digital PCR

Radiological evaluation5
Indication of surgery? (if yes type of surgery to be specified)
Evaluation of adverse events / effects: Tolerance of the previous treatment
Completion the source documents and the eCRF Clinical Exam1:

General State according to the WHO classification or according to the Karnowsky Index
Breast examination: inspection (symmetry, appearance of the skin), palpation (size of the tumor, presence of mammary discharge).
Examination of the axillary and supraclavicular lymph node areas
Abdominal examination
Pulmonary auscultation
Skeleton examination Radiological examination2:
Mammography and echo-mammary
Thoraco-abdomino-pelvic CT scan
Bone scintigraphy
Cardiac ultrasound Standard biochemical balance3: Blood group, creatininemia, blood ionogram, calcemia, glycemia, bilirubin, transaminases, gamma-GT, alkaline phosphatases, total cholesterol, triglycerides, uric acid, albuminemia. Histological examination4:
Biopsy with part number assigned by the laboratory, name of the laboratory
Histological type
Grade of Scarff-Bloom and Richardson (SBR)
Estrogen receptors, progesterone receptors
Her2Neu
Ki67
PD-L1
TILs
MMR Molecular Examination4:
MSI status by pentaplex PCR and capillary electrophoresis by NGS platform via the TruSight™ kit Oncology 500 (Illumina)
HRD Score by NGS platform via the TruSight™ kit Oncology 500 (Illumina)
Mutational burden TMB by NGS platform via the TruSight™ kit Oncology 500 (Illumina)
Circulating tumor DNA by digital PCR Radiological assessment5:
If the stage is locally advanced (appendix 3): Breast ultrasound +/- Mammography +/- Breast MRI
If metastatic stage: Thoraco-abdomino-pelvic CT scan 12 | 27 Visit details
Initial visit D0 (V1)
Signature of informed consent form
Verification of inclusion / non-inclusion criteria
Medical, surgical and family history
Current treatments
Clinical examination1
Radiological examinations2
TNM classification
Standard biochemical assessment3
Inflammatory assessment (CRP, LDH, IL6)
Hematological assessment (NFS, platelets)
Tumor markers (ACE, CA15-3)
Histological examination with immunohistochemistry and molecular4:
Biopsy with part number assigned by the lab, name of the lab
Histological type
SBR grade
Estrogen receptors, progesterone receptors
Her2Neu
Ki67
PD-L1
TILs
MMR
MSI
HRD
TMB mutational charge
ctDNA o Completion of source documents and eCRF
Visit after 3 chemotherapy treatment cycles (V2)
Current treatments
Clinical examination1
Hematological assessment (NFS, platelets)
Tumor markers (ACE, CA15-3)
Radiological assessment5
Evaluation of adverse events / effects: Tolerance of the previous treatment
Completion of source documents and eCRF
Assessment visit (V3) o Current treatments
Clinical examination1
TNM classification
Inflammatory assessment (CRP, LDH, IL6)
Hematological assessment (NFS, platelets)
Tumor markers (ACE, CA15-3)
Histological examination with immunohistochemistry and molecular4:
Biopsy with part number assigned by the lab, name of the lab
Histological type
SBR grade 13 | 27
Estrogen receptors, progesterone receptors
Her2Neu
Ki67
PD-L1
TILs
ctDNA
Radiological assessment5
Assessment of adverse events / effects
Fill in the source files and the eCRF
Follow-up visit at 3 months (V4)
Current treatments
Clinical examination1
Tumor markers (ACE, CA15-3)
Radiological examinations2
Evaluation of adverse events / effects
Completion of source documents and eCRF
Follow-up visit at 6 months (V5) o Current treatments o Clinical examination1 o Tumor markers (ACE, CA15-3)
Radiological examinations2
Evaluation of adverse events / effects
Completion of source documents and eCRF

Conditions: Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in Tunisia
Being tested: identify biomarkers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

identify biomarkersDiagnostic test
Identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma

What is being measured

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

number of eligible patients for immunotherapy
Identify the number of eligible patients for immunotherapy according to the epidemiological and biological profile
Measured: 2023 to 2027

Secondary outcomes (1)

Relevance of immunotherapy in Tunisia
Assess the relevance of the introduction of immunotherapy in Tunisia, by calculating the extension of the life expectancy (without disease and overall) of the patients who could benefit from this treatment, compared to the cost.
- Identify the sub-population of patients who benefit most from immunotherapy in Tunisia
Measured: 2023 to 2027

Timeline

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

Jun 2023Dec 2027

First posted23 May 2023
Study startJun 2023 (estimated)
Primary completionJun 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in TunisiaStudies of the same condition, open and under way.
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: Other
Time perspective: Prospective
Enrolment: 1,600 participants (estimated)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT05871788
Sponsor's protocol ID: ECOCS2020-01
Acronym: BIOPEACE
Status last verified: May 2023
First submitted: 13 May 2023
Last updated: 23 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biomarkers in Patients With Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT05871788
Acronym / sponsor ID: BIOPEACE / ECOCS2020-01
Conditions: Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in Tunisia
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 1,600 participants (estimated)
Lead sponsor: Tunisian Association for Immuno-oncology ResearchUniversity, hospital or other
Study start: Jun 2023 (estimated)
Primary completion: Jun 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 23 May 2023 (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.

It is also important to study other inflammatory and tumor biomarkers which would have a prognostic or even therapeutic value:

serum dosage of LDH (lactate dehydrogenase)
IL-6 (interleukin 6)
CRP (C-reactive protein)
absolute count of lymphocytes (CLA) and eosinophils
quantification of circulating tumor DNA before treatment and under treatment. The primary objective id to identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma before and during the systemic treatment.

Detailed description

Procedure:

Verification of the inclusion / non-inclusion criteria
Signing the consent form
Surgical, Medical and family history, ongoing treatments
Clinical Examination1
Radiological examinations 2
TNM Classification (Appendix 3)
Standard biochemical assessment 3
Inflammatory assessment (CRP, LDH, IL6)
Hematological assessment (NFS, platelets)
Tumor markers (ACE, CA15-3)
Histological and molecular examination 4:

Expression PD-L1 by IHC (Immuno-Histochemistry)
TILs by IHC
- MSI status: MMR * proteins (Mismatch Repair Protein) (Appendix 4) by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1>1%
Score HRD : by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1>1%
TMB mutational burden by next generation sequencing "Next Generation Sequencing" (NGS) via TruSight™ Oncology 500 Kit (Illumina) if PD-L1>1%
tDNA by digital PCR

Radiological evaluation5
Indication of surgery? (if yes type of surgery to be specified)
Evaluation of adverse events / effects: Tolerance of the previous treatment
Completion the source documents and the eCRF Clinical Exam1:

General State according to the WHO classification or according to the Karnowsky Index
Breast examination: inspection (symmetry, appearance of the skin), palpation (size of the tumor, presence of mammary discharge).
Examination of the axillary and supraclavicular lymph node areas
Abdominal examination
Pulmonary auscultation
Skeleton examination Radiological examination2:
Mammography and echo-mammary
Thoraco-abdomino-pelvic CT scan
Bone scintigraphy
Cardiac ultrasound Standard biochemical balance3: Blood group, creatininemia, blood ionogram, calcemia, glycemia, bilirubin, transaminases, gamma-GT, alkaline phosphatases, total cholesterol, triglycerides, uric acid, albuminemia. Histological examination4:
Biopsy with part number assigned by the laboratory, name of the laboratory
Histological type
Grade of Scarff-Bloom and Richardson (SBR)
Estrogen receptors, progesterone receptors
Her2Neu
Ki67
PD-L1
TILs
MMR Molecular Examination4:
MSI status by pentaplex PCR and capillary electrophoresis by NGS platform via the TruSight™ kit Oncology 500 (Illumina)
HRD Score by NGS platform via the TruSight™ kit Oncology 500 (Illumina)
Mutational burden TMB by NGS platform via the TruSight™ kit Oncology 500 (Illumina)
Circulating tumor DNA by digital PCR Radiological assessment5:
If the stage is locally advanced (appendix 3): Breast ultrasound +/- Mammography +/- Breast MRI
If metastatic stage: Thoraco-abdomino-pelvic CT scan 12 | 27 Visit details
Initial visit D0 (V1)
Signature of informed consent form
Verification of inclusion / non-inclusion criteria
Medical, surgical and family history
Current treatments
Clinical examination1
Radiological examinations2
TNM classification
Standard biochemical assessment3
Inflammatory assessment (CRP, LDH, IL6)
Hematological assessment (NFS, platelets)
Tumor markers (ACE, CA15-3)
Histological examination with immunohistochemistry and molecular4:
Biopsy with part number assigned by the lab, name of the lab
Histological type
SBR grade
Estrogen receptors, progesterone receptors
Her2Neu
Ki67
PD-L1
TILs
MMR
MSI
HRD
TMB mutational charge
ctDNA o Completion of source documents and eCRF
Visit after 3 chemotherapy treatment cycles (V2)
Current treatments
Clinical examination1
Hematological assessment (NFS, platelets)
Tumor markers (ACE, CA15-3)
Radiological assessment5
Evaluation of adverse events / effects: Tolerance of the previous treatment
Completion of source documents and eCRF
Assessment visit (V3) o Current treatments
Clinical examination1
TNM classification
Inflammatory assessment (CRP, LDH, IL6)
Hematological assessment (NFS, platelets)
Tumor markers (ACE, CA15-3)
Histological examination with immunohistochemistry and molecular4:
Biopsy with part number assigned by the lab, name of the lab
Histological type
SBR grade 13 | 27
Estrogen receptors, progesterone receptors
Her2Neu
Ki67
PD-L1
TILs
ctDNA
Radiological assessment5
Assessment of adverse events / effects
Fill in the source files and the eCRF
Follow-up visit at 3 months (V4)
Current treatments
Clinical examination1
Tumor markers (ACE, CA15-3)
Radiological examinations2
Evaluation of adverse events / effects
Completion of source documents and eCRF
Follow-up visit at 6 months (V5) o Current treatments o Clinical examination1 o Tumor markers (ACE, CA15-3)
Radiological examinations2
Evaluation of adverse events / effects
Completion of source documents and eCRF

Study design

Observational model: Other
Time perspective: Prospective
Target follow-up: 1 Year

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with metastatic or locally advanced breast cancer in Tunis, Tunisia.

Key inclusion criteria (8 listed)

Age ≥ 18 years old.
Signed informed consent
Histological evidence of breast carcinoma.
Locally advanced (stage III inoperable) or metastatic (stage IV) carcinoma, the metastases of which have been diagnosed straight away or after adjuvant or neoadjuvant treatment.
No treatment for metastatic disease.

Key exclusion criteria (6 listed)

Non-epithelial breast cancer
Non-biopsiable metastases
Patients who have received before systemic treatment for metastatic disease (chemotherapy, targeted therapy, hormone therapy)
Patients with a contraindication to chemotherapy, and / or hormone therapy, and
/ or targeted therapy.

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
identify biomarkersIdentify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma	Diagnostic test	–

Primary outcome

number of eligible patients for immunotherapy
Time frame: 2023 to 2027
Identify the number of eligible patients for immunotherapy according to the epidemiological and biological profile

1 secondary outcome

Relevance of immunotherapy in Tunisia
Time frame: 2023 to 2027

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
Individual participant dataSharing planned: Undecided

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.

Monia Malek, MD contact

00216 28 101 505

monia.malek@gmail.com

Questions about this trial

What is this clinical trial studying?

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 8 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: opening soon, as of the sponsor's last update on 23 May 2023. 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?

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 Monia Malek, MD (00216 28 101 505, monia.malek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of eligible patients for immunotherapy (time frame: 2023 to 2027). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05871788.

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 May 2023.