Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Lung Neoplasms

Colorectal Neoplasms

Stomach Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Diseases

Stomach Cancer

Le-Son Tran

Thi Van Phan

Trang Dao, Dr

This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA).

Primary objective: To evaluate the performance characteristics of the blood ctDNA test in early detecting cancers.

Secondary objectives:

* To evaluate the performance characteristics of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests.
* To determine the risk of cancers development in the high-risk population, as compared to that in the moderate-risk group.

This is a multi-centre, prospective cohort study recruiting participants aged 40 or above, who present at the Outpatient Clinic of the study hospitals either for periodically follow-up visits for their chronic conditions, or for annually health check-up. The study will be conducted at the Medical Genetic Institute, in collaboration with the University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam and other collaborating hospitals.

The potential participants, who satisfy all inclusion/exclusion criteria will be recruited into this study. These potential participants should not have history of cancer before being enrolled in the study.

At enrolment, each participant will answer to a pre-designed questionnaire to provide demographic information, past major medical history and clinical warning signs of cancers, and then provide 10mL of blood for analysing the circulating tumour DNA (ctDNA).

Each participant will get either ctDNA detected or ctDNA not detected.

For those having ctDNA detected in their blood, they will then undergo the screening and diagnostic tests for cancers based on the prediction of tumour origin provided in the test findings report. If the cancers lab-confirmed, patients will then be followed up and managed for their disease according to the guidelines of the Vietnam Ministry of Health and/or the international guidelines on cancers. At 12 months (+/- 1 week) following the enrolment, these patients will be contacted to collect information about their health, in general and their cancer status, in particular.

For those having ctDNA detected in their blood but the present of a mass inside participants' body could not be detected using the imaging diagnostic tests; and for those, who don't have ctDNA presenting in blood, phone calls will be made at 6 months (+/- 1 week) and 12 months (+/- 1 week) following the enrolment to collect information related to participants' health status as well as cancer progress (if possible).

The enrolment is anticipated to last for approximately 6 months.

Samples collected from the participants will be processed and analysed the ctDNA to detect cancer in the early stages and to predict the origin of the tumor. The residual blood of this test will be stored in -80 degree of Celcius for further testing to:- (i) screen or diagnose cancers; (ii) determine the hosts' genetic factors associated with the risks of cancers.

Early Detection of Five Common Cancers Using the ctDNA Analysing Test

Assessment of a Novel Blood Test in Early Detection of the Five Common Cancers Based on the Investigation of the Circulating Tumour DNA

Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organisation than authorized in the study.

Medical University of Ho Chi Minh City

Hanoi Medical University

Hanoi Oncology Hospital

Hue Central Hospital

Da Nang Oncology Hospital

Thong Nhat Dong Nai General Hospital

Dong Nai General Hospital

Van Hanh General Hospital

Can Tho Oncology Hospital

Medic Medical Center

Le Van Thinh Hospital

People's Hospital 115

Xuyen A Hospital

Medical Genetics Institute

Gene Solutions

Behaviors and Mental Disorders

Quality of Life

Comprehensive palliative care (CPC) is multidisciplinary inpatient care that aims to respond to patients' suffering in many aspects: physical, psychological, social, and spiritual. It is basically a standard palliative care service in Vietnam with additional psychosocial and spiritual support with a multidisciplinary approach. CPC is provided by seven doctors, 20 nurses, two social workers, a pharmacist, and a psychologist. CPC could go parallel with oncology care or be the primary care for patients.

The psychosocial and spiritual supports are mainly provided by social workers. Psychologist and religious will get involved when patient need advance care. The psychosocial intervention is individualized for each patient based on their individual situation, issues, and decision.

Patients who are randomized to the control group will receive the standard palliative care in Vietnam. They can assess to the same palliative care for their physical symptoms as patients in the intervention group do. They can also access psychosocial and spiritual support from the resources that available for them before entering to the study. If they request for social or financial support, their care team can reach out to the social work departments. Patients who are in need can receive mental health care from psychiatrists from the psychiatrist unit at UMC.

CPC is multidisciplinary inpatient care that aims to respond to patients' suffering in many aspects: physical, psychological, social, and spiritual. It is basically a standard palliative care service in Vietnam with additional psychosocial and spiritual support with a multidisciplinary approach.

Comprehensive palliative care

Standard of care

Quynh Truong, SW, MPH

There are exponential increases in cancer incidence and mortality worldwide and in Vietnam. Cancer affects patient's quality of life, which can be improved by palliative care. In Vietnam, due to a shortage in human resources for social workers, palliative care is mainly focused on medical aspect. A new comprehensive palliative care model, that provides multidisciplinary support including psychosocial support to patients, was developed. This research's objective is to evaluate the effectiveness of comprehensive palliative care (CPC) on improving the quality of life among cancer patients at a hospital in Vietnam.

This randomized control trial is performed among 100 advanced cancer patients at University Medical Center at Ho Chi Minh city, Vietnam.The measurement tools include the Vietnamese Palliative Care Outcome Scale (VietPOS), the 5-level EQ-5D (EQ-5D-5L), Hospital Anxiety and Depression Scale (HADS) and Zarit Burden Interview (ZBI). Data collection has been conducting through face-to-face interviews three times: baseline, week 3, and week 6. Paired t-test (or Wilcoxon Rank sum test) and Student-t-test (or Mann -Whitney U test) will be used to evaluate and compare changes in quality of life and psychological distress within and between groups. Intention- to - treat analysis is used in the study.

This is the first research that study the effectiveness of a palliative care psychosocial intervention on cancer patients in Vietnam. The result can be used to advocate for multidisciplinary palliative care in Vietnam.

Background Vietnam, a Southeast Asian country with a population of 97 million, is still facing both communicable and non-communicable conditions, in which cancer is on the rise. In a report by GLOBOCAN 2020, the number of new cancer cases were 182,563 cases with around 122,690 cancer deaths in 2020 (World Health Organization, 2020). Living and dying with cancer, patients not only cope with their long-term physical conditions but also deal with complex sufferings which significantly affect their quality of life (Arman, Rehnsfeldt et al, 2004; Cherny et al, 1994; Hui et al, 2015). Cancer patients suffer from clusters of symptoms from physical, psychosocial issues as pain (35-96%), anorexia (30-92%), depression (3-77%) (Solano, et al, 2006). A recent Vietnamese study in stage III and IV cancer patients found out that health related quality of life and general health were reported as bad and very bad in about 23% and 52% of patients, respectively. (Huyen et al., 2021) Palliative care is one of the essential components in cancer programs, along with prevention, early detection, diagnosis, and treatment to reduce the incidence, mortality from cancer, and improve the quality of life for cancer patients. (WHO, 2002). In 2006, Vietnam's MoH endorsed the very first national guideline for provision of palliative care in Vietnam (Krakauer et al., 2018). The traditional palliative care team in Vietnam consists of two main components of physician and nurse (Krakauer et al., 2018). However, surveys among those palliative care clinicians revealed that they felt more competent providing physical care than psychological, social, and spiritual care (Nguyen et al., 2014; Tsao et al., 2019) To further promote the role of social work in hospitals, the Vietnamese MoH issued Circular 43/2015/TT-BYT regulation on the required tasks and organizations of social work in hospital settings. Evidence of efficacy from palliative care social support provided by social workers is needed to advocate for more allocation of resources.

Aims and objectives The aim of this study is to evaluate the effectiveness of a multidisciplinary CPC on improving quality of life and psychological distress among advanced cancer patients at University Medical Center in Vietnam.

The first objective is to assess the effect of the multidisciplinary CPC on cancer patient's quality of life. The second objective is to assess the effect of the multidisciplinary CPC on cancer patient's psychological distress.

Methods/Design Setting CPC is an inpatient hospital based in the Palliative and Geriatrics Unit at the University of Medical Center in Ho Chi Minh city. Each year, it serves more than 2 million outpatients per day (approximately 7000 patients/day); 55,000 inpatients. The unit has 30 fixed bed capacity but could mobilize up to 20 beds from other wards when needed. The area has very limited resources for home-based palliative care and community services for hospice.

Recruitment procedure Participants are recruited among cancer patients referred to palliative care. The research coordinator sends the trial's information and an invitation to eligible patients, and to get the consent form.

Randomization and blinding Block randomization. Before the first participant enrolled, a researcher created a block randomization list (block size = 4) by using Sealed Envelope (Sealed Envelope Ltd, 2020). Each week, an independent research coordinator not involved in the treatment assigned patients who finished their consent forms into groups based on the order of the list. The study is an open-label study due to the type of intervention.

Data collection. Data was collected through face-to-face interviews by 5 nurses who were not in patients' care team. Training was provided to all the data collectors to reduced bias and ensure quality of the data. It is required to conduct the questionnaire with a reasonable amount of time that did not exhaust patients. The interview schedule was arranged by the trial coordinator, then email to the interviewers. Data was collected as soon as a patient enrolled to the study. Then data collection was repeated at 3rd week and 6th week.

Intervention arm CPC is multidisciplinary inpatient care that aims to respond to patients' suffering in many aspects: physical, psychological, social, and spiritual. It is basically a standard palliative care service in Vietnam with additional psychosocial and spiritual support with a multidisciplinary approach. CPC is provided by seven doctors, 20 nurses, two social workers, a pharmacist, and a psychologist. CPC could go parallel with oncology care or be the primary care for patients.

The clinical palliative care team in the CPC intervention is a comprehensive group of multidisciplinary professionals who share a common goal to help patients manage their life-limiting illnesses. The multidisciplinary team arrange a team meeting once a week to discuss all the cases. The team member will share their concerns and collaborate in care planning.

The psychosocial and spiritual supports are mainly provided by social workers. Psychologist and religious will get involved when patient need advance care. The psychosocial intervention is individualized for each patient based on their individual situation, issues, and decision. All assessments for patients' psychosocial and spiritual distresses were conducted in the first week after enrolling to CPC. Patients can be discharged in different time based on their treatment and health conditions. CPC intervention is continued after patients are discharge though telephone calls. Due to COVID pandemic, home visit is not appropriate.

Control arm Patients who are randomized to the control group will receive the standard palliative care in Vietnam. They can assess to the same palliative care for their physical symptoms as patients in the intervention group do. They can also access psychosocial and spiritual support from the resources that available for them before entering to the study. If they request for social or financial support, their care team can reach out to the social work departments. Patients who are in need can receive mental health care from psychiatrists from the psychiatrist unit at UMC.

Sample size calculation Based on a study by Margareta Brännström et al. (Brännström \& Boman, 2014), we estimated that a sample size of at least 41 participants in each group was needed to detect a mean difference of 8.60 in EQ-5D-5L score with a standard deviation of 13.70, and at 5% significance level, power of 80%. Due to the advanced stage of illness in the patients we estimated an attrition rate of 20% which meant that at least 50 participants were needed in each group.

Analysis We described and compared baseline data between the intervention and the control group using parametric and non-parametric tests as appropriate. We used t-test to compare the primary outcome, change in EQ-5D-5L after six weeks, between groups. Analyses of secondary outcomes included comparing domain of VietPOS, psychological distress and caregiver burden between groups. We used multiple imputation to deal with missing data. The alpha level for all statistical analyses was set at two-sided 0.05. All analyses were performed using R software.

Ethics approval Ethics approval for the study was gained from the ethics committee of University Medical Center at Ho Chi Minh city (Ref. 33/GCN-HĐĐĐ), obtained on 15/07/2020. The study protocol is retrospectively registered with ClinicalTrials.gov (NCT01165034). The delayed registration was due to the lack of human resource and technical support during the COVID-19 epidemics in Ho Chi Minh city, Vietnam.

Comprehensive Palliative Care for Cancer Patients in Vietnam

Effectiveness of Comprehensive Palliative Care on Improving Quality of Life and Psychological Distress Among Cancer Patients in Vietnam - a Randomized Control Trial

Primary outcome is the change of quality of life after assed by the change of the total score of the 5-level EQ-5D questionnaire. The 5-level EQ-5D version was introduced by the EuroQol Group in 2009. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.

The Vietnamese version of Palliative Care Outcome Scale was adapted and validated from the African-Palliative Outcome Scale in an unpublished study by a multi-institution research team of Dr Pham Thi Van Anh, Dr Eric Krakauer and Dr Richard Harding, endorsed by Vietnam's MoH. The Vietnamese Palliative Outcome Scale consists of 16 items, involving 4 domains: physical symptoms, psychological symptoms, psychosocial concerns, and caregiver concerns. Answers are given on a 6-point Likert scale, except for item 10, which is an open question on main problems experienced by the patient. The score for each item ranges from 0 to 5. The scores are calculated separately for patient and caregiver. Patient's symptom burden is calculated by 14 items for patient, total maximum score of 70, with higher scores meaning more severe burden. Caregiver's symptom burden is calculated by 8 items for caregiver, total maximum score of 40, with higher scores meaning more severe burden.

Depression and anxiety symptoms is assessed by the Vietnamese version of the Hospital Anxiety and Depression Score. The scores are reported separately for the Depression subscale and the Anxiety subscale. Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety

Carer burden is assessed with Zarit Burden Interview. The tool was developed by Zarit Bédard et al. in 2001 to measure subjective burden among caregivers of adults with dementia. The 22-item self-report version with each question is scored on a 5-point Likert scale ranging from - never (score 0) to nearly always present (score of 4). Total scores range from 0 (low burden) to 88 (high burden) with higher score correlating with greater caregiver burden

University Medical Center Ho Chi Minh City (UMC)

Vietnam Palliative Health Care Society

Liver Neoplasms

Liver Diseases

Le Son Tran, Ph.D

To evaluate the diagnostic performance of blood-based SPOT-MAS test in symptomatic individuals, the investigators sought to launch a prospective multicenter study, named K-ACCELERATE. The study aims to recruit 1,000 participants who develop symptoms and signs specific to the top five common cancer types including breast, colorectal, gastric, liver and lung cancer.

Primary objective: Evaluate the performance of the SPOT-MAS test in detecting cancer in symptomatic populations.

Secondary objectives: Evaluate the feasibility of incorporating SPOT-MAS as a triage test into primary care to increase the detection rates of malignant cancer while minimizing unnecessary referrals to invasive procedures.

Participants are recruited and referred to one of the five diagnosis pathways according to the participants' symptoms and signs listed.

Before undertaking imaging tests, 10 ml of blood is collected in Streck tube for SPOT-MAS test.

Participants undertake low-resolution imaging (LRI) tests matching with participants' referral diagnosis pathway. Imaging test results are returned within the same day.

If participants get negative results from both SPOT-MAS and LRI, participants will receive treatment for the symptoms based on the standard treatment scheme at hospitals and be followed up for 12 months to confirm their cancer-free status.

- If participants get a positive result from either SPOT-MAS or LRI, participants will be referred to high-resolution imaging tests (HRI) or tissue biopsy to confirm the presence of tumor.

For those with positive results confirming invasive tumors by HRI or tissue biopsy, patients will undergo treatment. The investigators do not provide financial support for their treatment.

For those with no invasive lesions but having positive SPOT-MAS results, participants will be advised to re-take the SPOT-MAS test after 6 months.

If the 2nd SPOT-MAS test results return positive, participants will be advised to perform whole body CT scan. If participants' scanning results return positive, participants will undergo tissue biopsy and treatment.

If the 2nd SPOT-MAS or whole body CT scan is negative, participants will be followed-up for an additional 6 months by surveying to confirm the cancer-free status.

The enrolment is anticipated to last for approximately 6 months

Samples collected from the participants will be processed and analysed the ctDNA to detect cancer in the early stages and to predict the origin of the tumor.

The residual blood of this test will be stored in -80 degree of Celcius for further testing to: (i) screen or diagnose cancers; (ii) determine the hosts' genetic factors associated with the risks of cancers

Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)

K-ACCELERATE: A Multi-center Prospective Trial to Evaluate Clinical Utility of Multi Cancer Early Detection Test as a Triage Test for Symptomatic Participants

Sensitivity, Specificity, Positive predictive value, Negative predictive value of the SPOT-MAS test

accuracy of tumor tissue origin identification

Positive predictive value, Negative predictive value, Sensitivity and Specificity of the SPOT-MAS test in combination with LRI and HRI tests

University of Medicine and Pharmacy at Ho Chi Minh City

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Lan NL Tu, PhD

VAN T Phan, MSc

Lan D Nguyen, PhD

VAN T Le, PhD

Sinh D Nguyen, PhD. MD

Sinh D Nguyen, PhD

This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC).

1. Determine relationship between ctDNA dynamics and clinical response to TKI,

   * No response/progressive disease = ctDNA levels increase from baseline
   * Partial response/stable disease = ctDNA levels decrease from baseline
   * Complete response = ctDNA clearance.
2. Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
3. Determine relationship between ctDNA dynamics and progression free survival, overall survival.

This study is recruiting female and male patients, aged 18 and older:

* Who are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed,
* Who have not started TKI / chemotherapy before enrollment,
* Who have no medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol,
* FFPE/FNA sample is available,
* Compliant with treatment protocol,
* Patients consented to participate in the study. As part of the protocol, demographic data, medical and family history, and any relevant prior concomitant medication data will be recorded during follow-up visits. All patients are to be followed for 2 years from enrollment, with CT scan imaging measured every clinical visit for 24 months.

Sample collection:

* 10 mL of peripheral blood (in Streck tubes) is collected for ctDNA analysis at 8 time points: pre-treatment (\<10 days before TKI), during TKI every 3 months until 21 months.
* 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples before TKI/chemotherapy treatment.

The 1st blood sample is collected from eligible participants of non-small cell lung cancer, stage IIIB-IV, before TKI and chemotherapy.

The 2nd -8th blood sample are collected from the participants every 3 months during TKI treatment, 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples before TKI and chemotherapy are also collected.

Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.

Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer

Anonymized data of this this study may be requested for publication by the journals, sharing anonymized data with suitable study will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organization than authority in the study.

* No response/progressive disease = ctDNA levels increase from baseline
* Partial response/stable disease = ctDNA levels decrease from baseline
* Complete response = ctDNA clearance.

* Correlation between ctDNA dynamics and clinical response
* Correlation between RECIST1.1 and clinical response
* Combination of ctDNA dynamics and RECIST v1.1 in the prognosis of clinical response.

* Correlation between ctDNA dynamics and PFS
* Correlation between ctDNA dynamics and OS.

Triple Negative Breast Neoplasms

Lan NL Tu, PHD

Van T. Phan, MSc

Sinh D. Nguyen, PhD. MD

Trung Q Lam, MD

Sinh D Nguyen, PHD

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.

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.

The 1st samples are collected from participants of Breast cancer, phase II-III, HER2+ /or Triple Negative breast cancer will be processed and analyzed to determine detection rate of ctDNA in the blood samples before neoadjuvant chemotherapy.

The 2nd and 3rd samples are collected from participants will be processed and analyzed to determine the change of ctDNA in the blood samples during and after neoadjuvant chemotherapy.

Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.

Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.

Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with suitable study will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be share with any other person/organization than authorized in the study.

* 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.

* 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Detection of Five Common Cancers Using the ctDNA Analysing Test	NCT05227261	Cancer, Lung Cancer, Breast Cancer Liver Cancer, Colorec... Liquid Biopsy Circulating Tum... Cancer, Gastric		40 Years -	Gene Solutions
Comprehensive Palliative Care for Cancer Patients in Vietnam	NCT05103488	Advanced Cancer Psychological D... Quality of Life	Comprehensive p... Standard of car...	18 Years - 70 Years	Vietnam Palliative Health Care Society
Early Detection of Five Common Cancers Using the ctDNA Analysing Test	NCT05227261	Cancer, Lung Cancer, Breast Cancer Liver Cancer, Colorec... Liquid Biopsy Circulating Tum... Cancer, Gastric		40 Years -	Gene Solutions
Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)	NCT06391749	Cancer Colon Cancer, Liver Cancer, Lung Cancer, Breast Cancer, Gastric		18 Years -	Gene Solutions
Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)	NCT06391749	Cancer Colon Cancer, Liver Cancer, Lung Cancer, Breast Cancer, Gastric		18 Years -	Gene Solutions
Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.	NCT06167460	Non Small Cell ... Stage IIIB Non-... Stage IIIC Non-... Stage IV Non-sm... Tyrosine Kinase...		18 Years - 80 Years	Gene Solutions
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.	NCT06087120	Breast Cancer F... Stage II Breast... Stage III Breas... HER2-positive B... Triple Negative...		18 Years -	Gene Solutions
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.	NCT06087120	Breast Cancer F... Stage II Breast... Stage III Breas... HER2-positive B... Triple Negative...		18 Years -	Gene Solutions

Spots Global Cancer Trial Database for vietnam

Every month we try and update this database with for vietnam cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vietnam

Every month we try and update this database with for vietnam cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vietnam cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.