Cancer of RectumBLENTINCT06940778
LIQUID BIOPSY FOCUSING ON CIRCULATING TUMOR CELLS AND CIRCULATING TUMOR DNA AS PRECISION MEDICINE IN GASTROINTESTINAL TUMORS
An observational study of Cancer of Rectum and Cancer of Pancreas, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
This is a prospective, observational, multicenter cohort study. Our main objective is to to evaluate the use of CTCs and ctDNA with prognostic factors in locally advanced rectal tumors treated with total neoadjuvant therapy (TNT), recently adopted as clinical practice, and to analyze the functionality of CTCs and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer of Rectum, Cancer of Pancreas, Cancer of Stomach
- How many people
- 273 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2025to 10 Dec 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: brazilian population
Who may be able to join
- Age ≥ 18 years;
- For locally advanced rectal cancer:
- Patients with histological confirmation of adenocarcinoma of the distal rectum who are candidates for sphincter preservation and undergoing TNT, a long-course CRT regimen, followed by CT (5-FU + consolidation oxaliplatin);
- Tumors with a location that requires rectal amputation, except for very early tumors (cT1N0);
- Absence of distant metastases (M0).
- For locally advanced or metastatic stomach cancer:
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- Patients with histological confirmation of adenocarcinoma of the stomach or esophagogastric junction (EGJ) (cT2-4, cN0-3, M0-1) who have not undergone any previous treatment for the disease, surgical or systemic;
- Patients who will undergo the following treatments:
- (T2 to T4, N+ and M0): 4 cycles of FLOT, surgery, + 4 cycles of FLOT (5-Fluorouracil, Oxaliplatin and Docetaxel);
- Initial cases: T2 to T4 N0: Surgery followed by adjuvant chemotherapy: CAPOX (capecitabine + oxaliplatin) or FOLFOX (5-Fluorouracil + capecitabine) - 8 cycles;
- Initially unresectable T4N3: If PDL1+ and CPS > 5: CT (FOLFOX or XELOX) + nivolumab. If HER-2 + XELOX or FOLOFX + transtuzumab - after 8 cycles evaluate resectability;
- Metastatic disease: if HER2 negative - XELOX or FOLFOX with Nivolumab or pembrolizumab. If HER2 positive XELOX or FOLFOX with trastuzumab + pembrolizumab.
- For localized or metastatic pancreatic cancer:
- Patients with histologically confirmed pancreatic adenocarcinoma (cT1-4, N0-2, M0-1) who have not undergone any prior surgical or systemic treatment for the disease.
- Patients who will undergo the following treatments:
- T1 to T3, N0 to N2 - resectable: Surgery followed by 12 cycles of FOLFIRINOX (oxaliplatin, 5-fluorouracil and irinotecan)
- Borderline resectable: Neoadjuvant chemotherapy with FOLFIRINOX for 8 cycles and surgery
- Unresectable disease - locally advanced: FOLFIRINOX for 12 cycles or Gemcitabine + nanoparticle paclitaxel for 8 cycles
Who cannot join
- Mid-rectum tumors or tumors with microsatellite instability.
- Stomach tumors or early EGJ (cT1N0)
- Patients who have undergone prior treatment or any surgical intervention in the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LIQUID BIOPSY FOCUSING ON CIRCULATING TUMOR CELLS (CTC) AND CIRCULATING TUMOR DNA (CTDNA) AS A PRECISION MEDICINE TOOL IN GASTROINTESTINAL TUMORS
This is a prospective, observational, multicenter cohort study. Our main objective is to to evaluate the use of CTCs and ctDNA with prognostic factors in locally advanced rectal tumors treated with total neoadjuvant therapy (TNT), recently adopted as clinical practice, and to analyze the functionality of CTCs and ctDNA in the follow-up of locally advanced and metastatic pancreatic and gastric tumors.
Secondary objectives:
- To verify the influence of CTC and ctDNA kinetics on the response to treatment of the three tumors;
- To correlate RAD23B/TYMS findings and CTC kinetics with DFS in locally advanced rectal tumors;
- To correlate HER-2 and PDL-1 expression in CTCs in gastric cancer with progression-free and overall survival;
- To verify the correlation between EGFR methylation in ctDNA of metastatic gastric tumors and PFS and OS;
- Correlate KRAS mutations in ctDNA in locally advanced pancreatic and rectal cancer with progression-free and overall survival;
- Compare the mutational profile of the primary tumor with that of the main components of the liquid biopsy (CTCs and ctDNA), in the three disease scenarios.
Read the detailed description
To evaluate CTCs we will isolate cells from blood of patients by ISET method (Rarecells, France). The DNA from CTCs will be evaluated by digital PCR (Qiagen). Also, the ctDNA. Patients will be evaluated three times ( before the beginning of therapy, 6 and 12 months later. The study will be only observational. Patients will be followed by clinical and images exams.
- Conditions
- Cancer of Rectum, Cancer of Pancreas, Cancer of Stomach
- Being tested
- No Interventions
- Keywords
- locally advanced rectal cancer, locally advanced and metastatic pancreas cancer, locally advanced and metastatic gastric cancer, circulating tumor cells, circulating tumor DNA, liquid biopsy
- Medical subject headings
- Rectal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
no interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
from the diagnosis of advanced disease to disease progression
Measured: from baseline (day 1) until the date of first documented progression , assessed up to 24months
Secondary outcomes (1)
overall survival
from the diagnosis of advanced or metastatic disease to death
Measured: from the day one until the date of death from any cause, assessed up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start10 Jan 2025
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer of RectumStudies 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
- 273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Amaral Carvalho, Brazil
- Responsible party
- Sponsor
- Investigators
- Ludmilla T.D. Chinen, PhD, Principal investigator, Hospital do CoracaoLUDMILLA T.D. CHINEN, PhD, Principal investigator, Hcor Biobank Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940778
- Sponsor's protocol ID
- BLENTI
- Other IDs
- 84562324.0.1001.0060, CONEP
- Acronym
- BLENTI
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we can share protocols and redecap data
Publications
Abdallah EA, Braun AC, Flores BCTCP, Senda L, Urvanegia AC, Calsavara V, Fonseca de Jesus VH, Almeida MFA, Begnami MD, Coimbra FJF, da Costa WL Jr, Nunes DN, Dias-Neto E, Chinen LTD. The Potential Clinical Implications of Circulating Tumor Cells and Circulating Tumor Microemboli in Gastric Cancer. Oncologist. 2019 Sep;24(9):e854-e863. doi: 10.1634/theoncologist.2018-0741. Epub 2019 Mar 7.
PubMed 30846515Silva VSE, Abdallah EA, Flores BCT, Braun AC, Costa DJF, Ruano APC, Gasparini VA, Silva MLG, Mendes GG, Claro LCL, Calsavara VF, Aguiar Junior S, de Mello CAL, Chinen LTD. Molecular and Dynamic Evaluation of Proteins Related to Resistance to Neoadjuvant Treatment with Chemoradiotherapy in Circulating Tumor Cells of Patients with Locally Advanced Rectal Cancer. Cells. 2021 Jun 18;10(6):1539. doi: 10.3390/cells10061539.
PubMed 34207124Tarazona JGR, Abdallah EA, Flores BCT, Braun AC, Camillo CMC, Marchi FA, Ruano APC, Chinen LTD. MIR-203A-3P AND MMP-2 PROTEINS ARE HIGHLY EXPRESSED IN CIRCULATING TUMOR CELLS FROM PATIENTS WITH PANCREATIC CARCINOMA. Arq Bras Cir Dig. 2022 Jan 31;34(4):e1628. doi: 10.1590/0102-672020210002e1628. eCollection 2022.
PubMed 35107490
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIQUID BIOPSY FOCUSING ON CIRCULATING TUMOR CELLS (CTC) AND CIRCULATING TUMOR DNA (CTDNA) AS A PRECISION MEDICINE TOOL IN GASTROINTESTINAL TUMORS
- ClinicalTrials.gov ID
- NCT06940778
- Acronym / sponsor ID
- BLENTI / BLENTI
- Conditions
- Cancer of Rectum, Cancer of Pancreas, Cancer of Stomach
- Keywords
- locally advanced rectal cancer, locally advanced and metastatic pancreas cancer, locally advanced and metastatic gastric cancer, circulating tumor cells, circulating tumor DNA, liquid biopsy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 273 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Fundação Amaral Carvalho, Brazil
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 23 Apr 2025 (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.
This is a prospective, observational, multicenter cohort study. Our main objective is to to evaluate the use of CTCs and ctDNA with prognostic factors in locally advanced rectal tumors treated with total neoadjuvant therapy (TNT), recently adopted as clinical practice, and to analyze the functionality of CTCs and ctDNA in the follow-up of locally advanced and metastatic pancreatic and gastric tumors.
Secondary objectives:
- To verify the influence of CTC and ctDNA kinetics on the response to treatment of the three tumors;
- To correlate RAD23B/TYMS findings and CTC kinetics with DFS in locally advanced rectal tumors;
- To correlate HER-2 and PDL-1 expression in CTCs in gastric cancer with progression-free and overall survival;
- To verify the correlation between EGFR methylation in ctDNA of metastatic gastric tumors and PFS and OS;
- Correlate KRAS mutations in ctDNA in locally advanced pancreatic and rectal cancer with progression-free and overall survival;
- Compare the mutational profile of the primary tumor with that of the main components of the liquid biopsy (CTCs and ctDNA), in the three disease scenarios.
Detailed description
To evaluate CTCs we will isolate cells from blood of patients by ISET method (Rarecells, France). The DNA from CTCs will be evaluated by digital PCR (Qiagen). Also, the ctDNA. Patients will be evaluated three times ( before the beginning of therapy, 6 and 12 months later. The study will be only observational. Patients will be followed by clinical and images exams.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- brazilian population
Key inclusion criteria (18 listed)
- Age ≥ 18 years;
- Patients with histological confirmation of adenocarcinoma of the distal rectum who are candidates for sphincter preservation and undergoing TNT, a long-course CRT regimen, followed by CT (5-FU + consolidation oxaliplatin);
- Tumors with a location that requires rectal amputation, except for very early tumors (cT1N0);
- Absence of distant metastases (M0).
- Patients with histological confirmation of adenocarcinoma of the stomach or esophagogastric junction (EGJ) (cT2-4, cN0-3, M0-1) who have not undergone any previous treatment for the disease, surgical or systemic;
Key exclusion criteria (3 listed)
- Mid-rectum tumors or tumors with microsatellite instability.
- Stomach tumors or early EGJ (cT1N0)
- Patients who have undergone prior treatment or any surgical intervention in the last 30 days.
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 |
|---|---|---|
| No Interventionsno interventions | Other | – |
Primary outcome
disease free survival
Time frame: from baseline (day 1) until the date of first documented progression , assessed up to 24months
from the diagnosis of advanced disease to disease progression
1 secondary outcome
overall survival
Time frame: from the day one until the date of death from any cause, assessed up to 30 months
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 27 Apr 2025.
- Background: PubMed 30846515Abdallah EA, Braun AC, Flores BCTCP, Senda L, Urvanegia AC, Calsavara V, Fonseca de Jesus VH, Almeida MFA, Begnami MD, Coimbra FJF, da Costa WL Jr, Nunes DN, Dias-Neto E, Chinen LTD. The Potential Clinical Implications of Circulating Tumor Cells and Circulating Tumor Microemboli in Gastric Cancer. Oncologist. 2019 Sep;24(9):e854-e863. doi: 10.1634/theoncologist.2018-0741. Epub 2019 Mar 7.
- Background: PubMed 34207124Silva VSE, Abdallah EA, Flores BCT, Braun AC, Costa DJF, Ruano APC, Gasparini VA, Silva MLG, Mendes GG, Claro LCL, Calsavara VF, Aguiar Junior S, de Mello CAL, Chinen LTD. Molecular and Dynamic Evaluation of Proteins Related to Resistance to Neoadjuvant Treatment with Chemoradiotherapy in Circulating Tumor Cells of Patients with Locally Advanced Rectal Cancer. Cells. 2021 Jun 18;10(6):1539. doi: 10.3390/cells10061539.
- Background: PubMed 35107490Tarazona JGR, Abdallah EA, Flores BCT, Braun AC, Camillo CMC, Marchi FA, Ruano APC, Chinen LTD. MIR-203A-3P AND MMP-2 PROTEINS ARE HIGHLY EXPRESSED IN CIRCULATING TUMOR CELLS FROM PATIENTS WITH PANCREATIC CARCINOMA. Arq Bras Cir Dig. 2022 Jan 31;34(4):e1628. doi: 10.1590/0102-672020210002e1628. eCollection 2022.
- we work with liquid biopsy since 2011, with many papers published in solid and mesenchymal tumors.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. we can share protocols and redecap data
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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.
Ludmilla T.D. Chinen, PhD principal investigator
Hospital do Coracao
LUDMILLA T.D. CHINEN, PhD principal investigator
Hcor Biobank Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Rectum and Cancer of Pancreas, run by Hospital do Coracao at 1 site in Brazil.
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 18 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 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 Brazil. 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?
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?
disease free survival (time frame: from baseline (day 1) until the date of first documented progression , assessed up to 24months). 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 NCT06940778, which also lists 3 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 27 Apr 2025.