Breast CarcinomaPERICAFSNCT06666517
The Relationship Between the Density of Cancer-Associated Fibroblasts in the Peritumoral Stroma and Clinicopathological Data in Breast Cancer Patients
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Immunohistochemistry Analysis and Second Biopsy in people with Breast Carcinoma, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Research Question: Is there a relationship between the clinical prognosis and pathological data of breast cancer patients and the density of cancer-associated fibroblasts in the peritumoral stroma? Objectives of the Study: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Immunohistochemistry Analysis and Second Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 27 Feb 2025
- 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
- Patients diagnosed with histopathologically confirmed Luminal B, HER2-positive, or triple-negative breast cancer subtypes.
- Patients who have not previously received any neoadjuvant chemoradiotherapy.
- Patients over 18 years of age.
- Adequate cellularity in biopsies obtained via core needle biopsy.
Who cannot join
- Patients diagnosed with histopathologically confirmed Luminal A breast cancer subtype.
- Patients who have previously received any neoadjuvant chemoradiotherapy.
- Patients under 18 years of age.
- Inadequate cellularity in biopsies obtained via core needle biopsy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpasa Numune Training and Research Hospital
Istanbul, Uskudar, 34668
About this study
Research Question:
Is there a relationship between the clinical prognosis and pathological data of breast cancer patients and the density of cancer-associated fibroblasts in the peritumoral stroma?
Objectives of the Study:
- Detection of cancer-associated fibroblasts in the tumor microenvironment across different breast cancer subtypes.
- Examination of the correlation between the clinical prognosis and pathological data of patients with different breast cancer subtypes and cancer-associated fibroblast subtypes.
The goal of this study based on the correlation obtained, the aim is to propose cancer-associated fibroblasts as a more effective marker for breast cancer classification and prognosis.
Read the detailed description
During the routine marking before neoadjuvant chemotherapy of breast cancer patients with triple-negative, HER2-positive, or Luminal B molecular subtypes, the correlation between the density of cancer-associated fibroblasts in the samples taken from the center of the tumor and the peritumoral stroma of the same mass with the patient's clinical prognosis and pathological data will be examined.
Approach and Methods:
Collection of Tissue Samples via Core Needle Biopsy from Breast Cancer Patients (Luminal B, HER2 Group, and Triple-Negative Group):
Breast masses will be examined supine using an ultrasound machine with a 14 MHz linear transducer. The tumor and peritumoral parenchyma will be evaluated using a 1.5 T MRI machine with a 16-channel breast coil, in the prone position, under dynamic contrast-enhanced and diffusion-weighted imaging guidance. Under sonographic guidance and local anesthesia, one tissue sample will be taken from the center of the mass using a 14G/10 cm core needle immediately before marking for neoadjuvant chemotherapy. One tissue sample will be taken from the peritumoral stroma where diffusion restriction is shown in diffusion-weighted MRI from patients diagnosed with Luminal B, HER2, or triple-negative malignancy.
Identification of Cancer-Associated Fibroblasts via Immunohistochemical Analysis:
For immunohistochemical analysis, 3 µm thick sections will be taken from paraffin blocks prepared from the core needle biopsy tissues from the periphery of the tumor, and the blocks will be deparaffinized in an incubator at 60 °C. The prepared slides will be stained using the LEICA Bond III fully automated IHC system, with the FAPα antibody, SMA antibody, and PDGFR-β antibody. Diaminobenzidine (DAB) will be used as the chromogen. Positive control tissues will include Fibroblast Activation Protein, alpha [SP325] Conc. 0.1mL (1:100) colon adenocarcinoma, Actin Smooth Muscle [1A4] Conc. 0.1mL (1:100-500) appendix, and PDGFR-B [D-6] C.Liq.1ml (1:50-500) kidney.
The immunohistochemical analysis of the patient under clinical follow-up will be compared with the type of surgery performed, the pathological data, and the clinical prognosis.
- Conditions
- Breast Carcinoma
- Being tested
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Immunohistochemistry Analysis, Second Biopsy
- Keywords
- cancer associated fibroblast, breast cancer, tumor microenvironment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesProcedure or surgery
Routine surgery after neoadjuvant chemotherapy for breast cancer according to current guidelines.
Immunohistochemistry AnalysisOther
Determination of breast cancer subtypes through immunohistochemical analysis, and selection of Luminal B, HER2-positive, and triple-negative groups.
Second BiopsyProcedure or surgery
Taking biopsies from the center of the tumor and the peritumoral stroma of the same mass during marking of the mass before neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1- Subtyping of Breast Cancer Patients. | Sham comparator | Biopsy collection from patients who were diagnosed with breast cancer, subtyping of biopsy materials, and identification of patients with Luminal A, Luminal B, HER2 positive group, and triple-negative types. Receives: Other: Immunohistochemistry Analysis |
| 5- Surgery Phase | Sham comparator | Surgery after neoadjuvant chemotherapy Receives: Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines |
| 2- Identification of patients to be included in the study. | No intervention | Identification of patients diagnosed with breast cancer who meet the study's eligibility criteria. |
| 3- Second Biopsy | Experimental | Taking biopsies from the center of the tumor and the peritumoral stroma of the same mass during marking of the mass before neoadjuvant chemotherapy Receives: Procedure: Second Biopsy |
| 4- Detection of cancer-associated fibroblasts | No intervention | Analysis of cancer-associated fibroblasts using immunohistochemical methods on materials taken from the periphery and center of patients' tumors during the second biopsy. |
| 6- Statistically Analyze | No intervention | The investigators compare cancer-associated fibroblast densities by analyzing monitored patients' clinical and pathological data and statistically analyze and interpret the results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Cancer-Associated Fibroblasts via Immunohistochemical Analysis
The detection of cancer-associated fibroblasts will be conducted separately using each immunohistochemical stain, and after the density(percentage) and intensity(will be scored 1 to 4) are assessed, the H-score(percentage X intensity score) will be determined by an expert pathologist, followed by grouping.
Measured: Within 4 weeks after immunohistochemical staining.
Secondary outcomes (1)
Collecting Patient Information From The Hospital System
Patients who underwent surgery after neoadjuvant chemotherapy will be monitored based on the following parameters in the pathology specimen: estrogen receptor(positive or negative), progesterone receptor(positive or negative), HER2 receptor(positive or negative), percentage of Ki67, nuclear grade(1,2 or 3), tumor diameter in centimeters, percentage of tumor-infiltrating lymphocytes, presence of in situ carcinoma, presence of multifocality, presence of lymphovascular invasion, residual cancer burden score(MD Anderson RCB Score) and clinically performed axillary and breast surgeries(breast sparing mastectomy, skin sparing mastectomy, nipple sparing mastectomy, modified radical mastectomy, axillary dissection or sentinel lymph node dissection), presence of recurrence and metastasis, whether they underwent reoperation, overall and disease-free survival in days and presence of mortality.
Measured: Within 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Apr 2021
- Primary completion15 Dec 2024
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dogukan Akkus, Haydarpasa Numune Training and Research Hospital
- Investigators
- Meryem Gunay Gurleyik, Medical Doctor, Study director, Haydarpasa Numune Training and Research Hsopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666517
- Sponsor's protocol ID
- HNEAH-GAEK 2024/149
- Other IDs
- Unit of Scientific Research
- Acronym
- PERICAFS
- Status last verified
- Mar 2025
- First submitted
- 8 Oct 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Everything can be accessible.
Publications
Giorello MB, Borzone FR, Labovsky V, Piccioni FV, Chasseing NA. Cancer-Associated Fibroblasts in the Breast Tumor Microenvironment. J Mammary Gland Biol Neoplasia. 2021 Jun;26(2):135-155. doi: 10.1007/s10911-020-09475-y. Epub 2021 Jan 4.
PubMed 33398516Barriga V, Kuol N, Nurgali K, Apostolopoulos V. The Complex Interaction between the Tumor Micro-Environment and Immune Checkpoints in Breast Cancer. Cancers (Basel). 2019 Aug 19;11(8):1205. doi: 10.3390/cancers11081205.
PubMed 31430935Wall SW, Echeverria GV. Avoiding Extinction: Cancer-Associated Fibroblasts Help Triple-Negative Breast Cancer Outrun Chemotherapy. Cancer Res. 2023 Nov 15;83(22):3667-3669. doi: 10.1158/0008-5472.CAN-23-2770.
PubMed 37964615Benyahia Z, Dussault N, Cayol M, Sigaud R, Berenguer-Daize C, Delfino C, Tounsi A, Garcia S, Martin PM, Mabrouk K, Ouafik L. Stromal fibroblasts present in breast carcinomas promote tumor growth and angiogenesis through adrenomedullin secretion. Oncotarget. 2017 Feb 28;8(9):15744-15762. doi: 10.18632/oncotarget.14999.
PubMed 28178651Eiro N, Gonzalez LO, Fraile M, Cid S, Schneider J, Vizoso FJ. Breast Cancer Tumor Stroma: Cellular Components, Phenotypic Heterogeneity, Intercellular Communication, Prognostic Implications and Therapeutic Opportunities. Cancers (Basel). 2019 May 13;11(5):664. doi: 10.3390/cancers11050664.
PubMed 31086100Salimifard S, Masjedi A, Hojjat-Farsangi M, Ghalamfarsa G, Irandoust M, Azizi G, Mohammadi H, Keramati MR, Jadidi-Niaragh F. Cancer associated fibroblasts as novel promising therapeutic targets in breast cancer. Pathol Res Pract. 2020 May;216(5):152915. doi: 10.1016/j.prp.2020.152915. Epub 2020 Mar 2.
PubMed 32146002Pelon F, Bourachot B, Kieffer Y, Magagna I, Mermet-Meillon F, Bonnet I, Costa A, Givel AM, Attieh Y, Barbazan J, Bonneau C, Fuhrmann L, Descroix S, Vignjevic D, Silberzan P, Parrini MC, Vincent-Salomon A, Mechta-Grigoriou F. Cancer-associated fibroblast heterogeneity in axillary lymph nodes drives metastases in breast cancer through complementary mechanisms. Nat Commun. 2020 Jan 21;11(1):404. doi: 10.1038/s41467-019-14134-w.
PubMed 31964880
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Density of Cancer-Associated Fibroblasts in the Peritumoral Stroma and Clinicopathological Data in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06666517
- Acronym / sponsor ID
- PERICAFS / HNEAH-GAEK 2024/149
- Conditions
- Breast Carcinoma
- Keywords
- cancer associated fibroblast, breast cancer, tumor microenvironment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 30 Oct 2024 (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.
Research Question:
Is there a relationship between the clinical prognosis and pathological data of breast cancer patients and the density of cancer-associated fibroblasts in the peritumoral stroma?
Objectives of the Study:
- Detection of cancer-associated fibroblasts in the tumor microenvironment across different breast cancer subtypes.
- Examination of the correlation between the clinical prognosis and pathological data of patients with different breast cancer subtypes and cancer-associated fibroblast subtypes.
The goal of this study based on the correlation obtained, the aim is to propose cancer-associated fibroblasts as a more effective marker for breast cancer classification and prognosis.
Detailed description
During the routine marking before neoadjuvant chemotherapy of breast cancer patients with triple-negative, HER2-positive, or Luminal B molecular subtypes, the correlation between the density of cancer-associated fibroblasts in the samples taken from the center of the tumor and the peritumoral stroma of the same mass with the patient's clinical prognosis and pathological data will be examined.
Approach and Methods:
Collection of Tissue Samples via Core Needle Biopsy from Breast Cancer Patients (Luminal B, HER2 Group, and Triple-Negative Group):
Breast masses will be examined supine using an ultrasound machine with a 14 MHz linear transducer. The tumor and peritumoral parenchyma will be evaluated using a 1.5 T MRI machine with a 16-channel breast coil, in the prone position, under dynamic contrast-enhanced and diffusion-weighted imaging guidance. Under sonographic guidance and local anesthesia, one tissue sample will be taken from the center of the mass using a 14G/10 cm core needle immediately before marking for neoadjuvant chemotherapy. One tissue sample will be taken from the peritumoral stroma where diffusion restriction is shown in diffusion-weighted MRI from patients diagnosed with Luminal B, HER2, or triple-negative malignancy.
Identification of Cancer-Associated Fibroblasts via Immunohistochemical Analysis:
For immunohistochemical analysis, 3 µm thick sections will be taken from paraffin blocks prepared from the core needle biopsy tissues from the periphery of the tumor, and the blocks will be deparaffinized in an incubator at 60 °C. The prepared slides will be stained using the LEICA Bond III fully automated IHC system, with the FAPα antibody, SMA antibody, and PDGFR-β antibody. Diaminobenzidine (DAB) will be used as the chromogen. Positive control tissues will include Fibroblast Activation Protein, alpha [SP325] Conc. 0.1mL (1:100) colon adenocarcinoma, Actin Smooth Muscle [1A4] Conc. 0.1mL (1:100-500) appendix, and PDGFR-B [D-6] C.Liq.1ml (1:50-500) kidney.
The immunohistochemical analysis of the patient under clinical follow-up will be compared with the type of surgery performed, the pathological data, and the clinical prognosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1- Subtyping of Breast Cancer Patients. | Sham comparator | Other: Immunohistochemistry AnalysisBiopsy collection from patients who were diagnosed with breast cancer, subtyping of biopsy materials, and identification of patients with Luminal A, Luminal B, HER2 positive group, and triple-negative types. |
| 5- Surgery Phase | Sham comparator | Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesSurgery after neoadjuvant chemotherapy |
| 2- Identification of patients to be included in the study. | No intervention | –Identification of patients diagnosed with breast cancer who meet the study's eligibility criteria. |
| 3- Second Biopsy | Experimental | Procedure: Second BiopsyTaking biopsies from the center of the tumor and the peritumoral stroma of the same mass during marking of the mass before neoadjuvant chemotherapy |
| 4- Detection of cancer-associated fibroblasts | No intervention | –Analysis of cancer-associated fibroblasts using immunohistochemical methods on materials taken from the periphery and center of patients' tumors during the second biopsy. |
| 6- Statistically Analyze | No intervention | –The investigators compare cancer-associated fibroblast densities by analyzing monitored patients' clinical and pathological data and statistically analyze and interpret the results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with histopathologically confirmed Luminal B, HER2-positive, or triple-negative breast cancer subtypes.
- Patients who have not previously received any neoadjuvant chemoradiotherapy.
- Patients over 18 years of age.
- Adequate cellularity in biopsies obtained via core needle biopsy.
Key exclusion criteria (4 listed)
- Patients diagnosed with histopathologically confirmed Luminal A breast cancer subtype.
- Patients who have previously received any neoadjuvant chemoradiotherapy.
- Patients under 18 years of age.
- Inadequate cellularity in biopsies obtained via core needle biopsy.
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 |
|---|---|---|
| surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesRoutine surgery after neoadjuvant chemotherapy for breast cancer according to current guidelines. | Procedure or surgery | 5- Surgery Phase |
| Immunohistochemistry AnalysisDetermination of breast cancer subtypes through immunohistochemical analysis, and selection of Luminal B, HER2-positive, and triple-negative groups. | Other | 1- Subtyping of Breast Cancer Patients. |
| Second BiopsyTaking biopsies from the center of the tumor and the peritumoral stroma of the same mass during marking of the mass before neoadjuvant chemotherapy | Procedure or surgery | 3- Second Biopsy |
Primary outcome
Detection of Cancer-Associated Fibroblasts via Immunohistochemical Analysis
Time frame: Within 4 weeks after immunohistochemical staining.
The detection of cancer-associated fibroblasts will be conducted separately using each immunohistochemical stain, and after the density(percentage) and intensity(will be scored 1 to 4) are assessed, the H-score(percentage X intensity score) will be determined by an expert pathologist, followed by grouping.
1 secondary outcome
Collecting Patient Information From The Hospital System
Time frame: Within 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 33398516Giorello MB, Borzone FR, Labovsky V, Piccioni FV, Chasseing NA. Cancer-Associated Fibroblasts in the Breast Tumor Microenvironment. J Mammary Gland Biol Neoplasia. 2021 Jun;26(2):135-155. doi: 10.1007/s10911-020-09475-y. Epub 2021 Jan 4.
- Background: PubMed 31430935Barriga V, Kuol N, Nurgali K, Apostolopoulos V. The Complex Interaction between the Tumor Micro-Environment and Immune Checkpoints in Breast Cancer. Cancers (Basel). 2019 Aug 19;11(8):1205. doi: 10.3390/cancers11081205.
- Background: PubMed 37964615Wall SW, Echeverria GV. Avoiding Extinction: Cancer-Associated Fibroblasts Help Triple-Negative Breast Cancer Outrun Chemotherapy. Cancer Res. 2023 Nov 15;83(22):3667-3669. doi: 10.1158/0008-5472.CAN-23-2770.
- Background: PubMed 28178651Benyahia Z, Dussault N, Cayol M, Sigaud R, Berenguer-Daize C, Delfino C, Tounsi A, Garcia S, Martin PM, Mabrouk K, Ouafik L. Stromal fibroblasts present in breast carcinomas promote tumor growth and angiogenesis through adrenomedullin secretion. Oncotarget. 2017 Feb 28;8(9):15744-15762. doi: 10.18632/oncotarget.14999.
- Background: PubMed 31086100Eiro N, Gonzalez LO, Fraile M, Cid S, Schneider J, Vizoso FJ. Breast Cancer Tumor Stroma: Cellular Components, Phenotypic Heterogeneity, Intercellular Communication, Prognostic Implications and Therapeutic Opportunities. Cancers (Basel). 2019 May 13;11(5):664. doi: 10.3390/cancers11050664.
- Background: PubMed 32146002Salimifard S, Masjedi A, Hojjat-Farsangi M, Ghalamfarsa G, Irandoust M, Azizi G, Mohammadi H, Keramati MR, Jadidi-Niaragh F. Cancer associated fibroblasts as novel promising therapeutic targets in breast cancer. Pathol Res Pract. 2020 May;216(5):152915. doi: 10.1016/j.prp.2020.152915. Epub 2020 Mar 2.
- Background: PubMed 31964880Pelon F, Bourachot B, Kieffer Y, Magagna I, Mermet-Meillon F, Bonnet I, Costa A, Givel AM, Attieh Y, Barbazan J, Bonneau C, Fuhrmann L, Descroix S, Vignjevic D, Silberzan P, Parrini MC, Vincent-Salomon A, Mechta-Grigoriou F. Cancer-associated fibroblast heterogeneity in axillary lymph nodes drives metastases in breast cancer through complementary mechanisms. Nat Commun. 2020 Jan 21;11(1):404. doi: 10.1038/s41467-019-14134-w.
- Individual participant dataSharing planned: Yes. Everything can be accessible.
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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.
Meryem Gunay Gurleyik, Medical Doctor study director
Haydarpasa Numune Training and Research Hsopital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Immunohistochemistry Analysis and Second Biopsy in people with Breast Carcinoma, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 13 Mar 2025. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection of Cancer-Associated Fibroblasts via Immunohistochemical Analysis (time frame: Within 4 weeks after immunohistochemical staining.). 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 NCT06666517, which also lists 7 linked publications.
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 13 Mar 2025.