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Trial Title:
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
NCT ID:
NCT06087120
Condition:
Breast Cancer Female
Stage II Breast Cancer
Stage III Breast Cancer
HER2-positive Breast Cancer
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
Liquid Biopsy
Circulating Tumour DNA
Vietnam
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
This is a prospective and observational study, aiming to determine the detection rate and
change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant
treatment.
- Determine the rate of ctDNA positivity at the time before treatment,
- Determine the rate of ctDNA positivity at the time during treatment,
- Determine the rate of ctDNA positivity at the time after neoadjuvant therapy,
whether there is a change in ctDNA expression of the study population during
treatment.
And aiming to investigate the relationship between ctDNA expression and MRI imaging with
pCR response in neo-adjuvant therapy:
- Correlation between ctDNA detection and pCR response. Determine the percentage of
Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA,
- Correlation between MRI imaging and pCR response. Determination of PPV, NPV of MRI
- Combination of ctDNA detection and MRI imaging in the prognosis of pCR.
Determination of PPV, NPV ratio of ctDNA combined with MRI.
Detailed description:
This is a prospective and observational study recruiting Female participants aged 18 and
older, who are diagnosed with stage II-III HER+/Triple Negative Breast cancer and
indicated for neoadjuvant chemotherapy at University Medical Center HCMC, had FFPE sample
at the time of diagnosis and operation. This study is conducted at the Medical Genetics
Institute (MGI), in collaboration with the University Medical Center HCMC.
Eligible neoadjuvant chemotherapy (NAC) / treatment regimen for the study:
- AC-T (Doxorubicin, Cyclophosphamid - Taxane).
- AC-TH (Doxorubicin, Cyclophosphamid - Taxane - Trastuzumab).
- TCH (Docetaxel - Carboplatin - Trastuzumab).
- TCHP (Docetaxel - Carboplatin - Trastuzumab - Pertuzumab).
Patients are allowed to change protocol if required clinically.
The potential and voluntary participants, satisfy all the inclusion/exclusion criteria
will be recruited into this study.
At enrollment, each participant will answer to the pre-designed questionnaires of
demographic information, medical history.
At routine visits, the participants' clinical information and routine para-clinical
results such as breast ultrasound or MRI or CT scan, chest x-ray, mamography, bone or
PET-CT scan, CA 15-3 will be collected by Physicians.
Participant in this study will have samples collected the following period of time.
- At enrollment (Pre-NAC, at diagnosis): 10ml of peripheral blood for ctDNA analysis
and 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples collected
as biopsy before treatment.
- During NAC, 10ml of peripheral blood will be collected for ctDNA analysis and
Ultrasound scan of neck, breast, abdomen and pelvis; chest x-ray, CA15-3; CT Scan of
the neck, abdomen and pelvis (if any) will be also collected.
- Post-NAC, 10ml of peripheral blood will be collected for ctDNA analysis and
Ultrasound scan of neck, breast, abdomen and pelvis; chest x-ray, CA15-3; CT Scan of
the neck, abdomen and pelvis, PET-CT scan (if any) will be also collected to compare
to treatment respondence between ctDNA and imaging groups.
- After surgery, 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples
collected.
The study end date of a participant is estimated 1 year since enrollment date.
Criteria for eligibility:
Study pop:
The study population will include female, from 18 years old or above, who are diagnosed
with stage II-III HER2+/Triple Negative breast cancer and indicated for neoadjuvant
chemotherapy. Eligible participants will meet all of the inclusion and exclusion criteria
to be recruited into this study at University Medical Center HCMC.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Female,18 years old and older,
- Are diagnosed with stage II-III HER2+/Triple Negative breast cancer and indicated
for neoadjuvant chemotherapy,
- FFPE sample is available at the time of diagnosis and operation,
- Are voluntary to participate in the study.
Exclusion Criteria:
- Recurrent breast cancer,
- Other cancer metastasis to the breast,
- Have been or are being treated for cancer,
- Patients did not agree to participate in the studies.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical Genetics Institute
Address:
City:
Ho Chi Minh City
Country:
Vietnam
Status:
Recruiting
Contact:
Last name:
Lan NL Tu, PhD
Phone:
+84888843489
Email:
lantu@genesolutions.vn
Investigator:
Last name:
Sinh D. Nguyen, PhD. MD
Email:
Principal Investigator
Facility:
Name:
University Medical Center HCMC
Address:
City:
Ho Chi Minh City
Country:
Vietnam
Status:
Recruiting
Contact:
Last name:
Trung Q Lam, MD
Investigator:
Last name:
Trung Q Lam, MD
Email:
Principal Investigator
Start date:
September 16, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Gene Solutions
Agency class:
Industry
Source:
Gene Solutions
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06087120
http://thuvienphapluat.vn/van-ban/The-thao-Y-te/Quyet-dinh-3128-QD-BYT-2020-tai-lieu-chuyen-mon-Huong-dan-chan-doan-dieu-tri-ung-thu-vu-447853.aspx
