Rectal CancerLIMANCT04224779
Liquid Biopsies and IMAging for Improved Cancer Care
A study testing Biological collection in people with Rectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The recently developed liquid biopsy technology (to obtain and characterize tumour cells and tumour components like Deoxyribonucleic acid (DNA) or Ribonucleic Acid (RNA) from a simple blood draw), in combination with advanced Magnetic Resonance Imaging techniques (MRI), can tackle the following problems in rectal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Biological collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2021to May 2027
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Histologically-confirmed diagnosis of adenocarcinoma of the rectum
- Distal part of the tumour within 2 to 12 cm of the anal margin
- Candidate for Neoadjuvant chemotherapy (NAT)
- Measurable disease (using the Recist criteria v1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Show all 10Show fewer
- General condition considered suitable for radical pelvic surgery
- Adequate bone marrow, hepatic and renal function
- Willing to participate to the study, and able to give informed consent and to comply with the treatment and follow-up schedules
- Patient being able to follow all the treatment as well as the follow-ups planned in this study
Who cannot join
- Patient with metastatic disease
- Symptomatic cardiac or coronary insufficiency
- Severe renal insufficiency
- Progressive active infection or any other severe medical condition
- Other cancer treated within the last 5 years except in situ cervical carcinoma or basocellular/ spinocellular carcinoma
- Pregnant or breast-feeding woman
Show all 9Show fewer
- Unaffiliated patient to French Social Protection System
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
Trial locations and contacts
1 site in 1 country.
France1 site
Insitut Régional du Cancer de Montpellier
Montpellier, Hérault, 34298
About this study
Official title: Liquid Biopsies and IMAging for Improved Cancer Care - Non Metastatic Rectal Cancer
The recently developed liquid biopsy technology (to obtain and characterize tumour cells and tumour components like Deoxyribonucleic acid (DNA) or Ribonucleic Acid (RNA) from a simple blood draw), in combination with advanced Magnetic Resonance Imaging techniques (MRI), can tackle the following problems in rectal cancer: 1. Assessment of tumour heterogeneity from liquid biopsies. 2. Assessment from advanced MRI feature extraction to indicate poor outcome 3. Faster assessment of therapy response in Neoadjuvant chemotherapy (NAT) for rectal cancer; 4. Detection of emerging drug/therapy resistance. This project's overall objective is to develop and validate technologies and tools to include liquid biopsies in the clinical workflow, aiming at introducing a more precise and dynamic genetic characterization of tumour at the diagnosis and during treatment phases.
Read the detailed description
According to the Global cancer observatory database (Globocan) estimates, there are 447,136 new cases of Colo-Rectal Cancer (CRC) in Europe annually. This makes CRC the 2nd most common cancer in Europe, accounting for 13.0% of all cancers in 2012 with an estimate of 214,866 deaths from CRC in Europe (12.2% of the total number of cancer deaths, 2nd most common cause of cancer related deaths). In LIMA, the rectal cancer patient sub-group of CRC will be studied, comprising some 80,000 patients annually, as these patients are treated in neoadjuvant setting. Moreover, ineffective NeoAdjuvant Treatment (NAT) in rectal cancer patients will results in surgery with severe side effect, making stratification of patients according to their Neoadjuvant Chemotherapy (NAT) response a real challenge for this pathology.
Cancer is a very heterogeneous disease characterized by high variability of response to therapy. In general, it is unknown which cancers will respond to a certain therapy and which will not. Overall trend is to come to less invasive and more personalized treatment. Personalized medicine for cancer patients aims to tailor the best treatment options for the individual at diagnosis and during treatment. This requires accurate patient stratification based on molecular profiling of the tumour and its heterogeneity, not only at the first diagnosis but during the whole treatment. Treatment of cancer is associated with significant comorbidity and reduced quality of life, especially when an organ like the rectum, would need to be surgically removed to increase chances of curation of the disease. But also side-effects of treatment are important to consider. In the past decade the use of NAT has emerged as an effective therapeutic approach to reduce tumour volume and aggressiveness prior to surgery, resulting in increased chances at curative resection and saving the organ and to test sensitivity of a tumour to a therapy that will be used in adjuvant setting following surgery. The development of drugs that target tumour driving signal transduction pathways provides a very effective set of new cancer drugs to choose from in the neoadjuvant or adjuvant setting. This is based however on the premise that the tumour driving pathway is accurately defined in the tumour tissue and the appropriate targeted drug is selected. Using these drugs requires a personalized approach with careful matching of patient to drug therapy. In the neoadjuvant setting this poses a challenge, since tumours can be heterogenic with respect to the tumour driving signalling pathways, especially when high grade and larger sized. In such a case, multiple biopsies would need to be taken to enable accurate characterization of the whole tumour. Unfortunately this is often not feasible, while recent insights suggest that resulting inflammation of the tumour microenvironment may contribute to a more aggressive behaviour of the cancer cells. Another challenge in neoadjuvant treatment is early assessment of therapy response, to enable timely switching to another, more effective therapy in case of a non-response. In addition, in the case of use of targeted drugs, emerging resistance can be a problem, which should be detected as soon as possible. Aim of this project is to improve monitoring of patients' response at the diagnosis and during neoadjuvant treatment, to stratify the good and poor responders to Neoadjuvant chemotherapy (NAT), earlier and better than is currently possible.
The recently developed liquid biopsy technology (to obtain and characterize tumour cells and tumour components like Deoxyribonucleic Acid (DNA) or Ribonucleic Acid (RNA) from a simple blood draw), in combination with advanced Magnetic Resonance Imaging techniques (MRI), can tackle the following problems: 1. Assessment of tumour heterogeneity from liquid biopsies. 2. Assessment from advanced MRI feature extraction to indicate poor outcome 3. Faster assessment of therapy response in NAT for rectal cancer; 4. Detection of emerging drug/therapy resistance. This project overall objective is to develop and validate technologies and tools to include liquid biopsies in the clinical workflow, aiming at introducing a more precise and dynamic genetic characterization of tumour at the diagnosis and during treatment phases.
- Conditions
- Rectal Cancer
- Being tested
- Biological collection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological collectionBiological
The biological collection will include samples of blood samples collected at different times but also tumoral biopsy before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Tumors and blood collection | Experimental | For all the patients included in the study :
* Blood samples will be collected at different times T1 (Baseline), T2 (1 or 2 weeks after the beginning of the treatment), T3 (3 or 4 weeks before the surgery) and T4 (1 month after the surgery).
* Tumors biopsy will be collected for some patients who will benefit from an initial biopsy in the course of his management care in our Institute (before the surgery).
In parallel to this biological collection, imaging and clinical data will be entered into a database treatment. Receives: Biological: Biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Receiver Operating Characteristic (ROC) curve of total cfDNA (defined as circulating cell-free DNA in plasma) percent change between the baseline sample (T1) and the sample at the end of the neo-adjuvant treatment (T3)
This change of circulating free DeoxyriboNucleic Acid (cfDNA) percent will be correlated with the pathological complete response (defined as Grade 3 and 4 of Dworak definition) to neo-adjuvant treatment
Pathological response (at surgery) is defined as Dworak definition below:
- No regression (0),
- Predominantly tumour with significant fibrosis and/or vasculopathy (1),
- Predominantly fibrosis with scattered tumour cells (slightly recognizable histologically) (2),
- Only scattered tumour cells in the space of fibrosis with / without acellular mucin (3)
- No vital tumour cells detectable (4).
Measured: Through study completion, an average of 3.5 years
Secondary outcomes (12)
Area under the Receiver Operating Characteristic (ROC) curve of the total cfDNA percent change between the baseline sample (T1) and the first sample during the neo-adjuvant treatment (T2)
This change of circulating free DeoxyriboNucleic Acid (cfDNA) percent will be correlated with the pathological complete response
Measured: Through study completion, an average of 3.5 years
Area under the Receiver Operating Characteristic (ROC) curve of the mutant cfDNA percent change between the baseline sample (T1) and the first sample during the neo-adjuvant treatment (T2) [resp the sample at the end of neo-adjuvant treatment (T3)]
This change of circulating free DeoxyriboNucleic Acid (cfDNA) percent will be correlated with the pathological complete response
Measured: Through study completion, an average of 3.5 years
Number of Circulating tumor cells (CTCs) found in blood
Measured: Through study completion, an average of 3.5 years
Tumoral response assessed by Magnetic resonance Imaging (MRI)
Tumor evaluation will be evaluated according to "DISTANCE" parameters
Measured: Through study completion, an average of 3.5 years
Response to treatment by using a radiomics algorythm
The term radiomics has been defined as high-throughput extraction of quantitative features that results in the conversion of images into mineable data
Measured: Through study completion, an average of 3.5 years
Sensibility (Se) of the total cfDNA percent change and the mutant cfDNA percent change
Between the baseline (sample T1) and the first sample during the neo-adjuvant treatment (T2) [respectively the sample at the end of neo-adjuvant treatment (T3)] and the complete pathological response to neo-adjuvant treatment
Mutant cftDNA is defined as cfDNA bearing the mutations detected from RAS, BRAF and PIK3CA
Measured: Through study completion, an average of 3.5 years
Specificity (Se) of the total cfDNA percent change and the mutant cfDNA percent change
Between the baseline (sample T1) and the first sample during the neo-adjuvant treatment (T2) [respectively the sample at the end of neo-adjuvant treatment (T3)] and the complete pathological response to neo-adjuvant treatment
Mutant cftDNA is defined as cfDNA bearing the mutations detected from RAS, BRAF and PIK3CA
Measured: Through study completion, an average of 3.5 years
Predictive Positive Value (PPV) of the total cfDNA percent change and the mutant cfDNA percent change
Between the baseline (sample T1) and the first sample during the neo-adjuvant treatment (T2) [respectively the sample at the end of neo-adjuvant treatment (T3)] and the complete pathological response to neo-adjuvant treatment.
Mutant cftDNA is defined as cfDNA bearing the mutations detected from RAS, BRAF and PIK3CA
Measured: Through study completion, an average of 3.5 years
Predictive Negative Value (PNV) of the total cfDNA percent change and the mutant cfDNA percent change
Between the baseline (sample T1) and the first sample during the neo-adjuvant treatment (T2) [respectively the sample at the end of neo-adjuvant treatment (T3)] and the complete pathological response to neo-adjuvant treatment
Mutant cftDNA is defined as cfDNA bearing the mutations detected from RAS, BRAF and PIK3CA
Measured: Through study completion, an average of 3.5 years
The number of molecular signal transduction pathway that appear in addition to the wingless integration site (Wnt) pathway at T1, T2, T3 and T4
Measured: Through study completion, an average of 3.5 years
Tumoral response assessed by Magnetic resonance Imaging (MRI)
Tumor volumetry will be performed manually, tracing the tumor boundaries on the axial oblique images on T2W-MR images in conjunction with the highest b value image as to exclude areas of T2 fibrosis and include only the residual tumor
Measured: Through study completion, an average of 3.5 years
Tumoral response assessed by Magnetic resonance Imaging (MRI)
The mrTRG will be also evaluated to determine the degree of tumor replacement by fibrotic or mucinous changes stroma. Favorable mrTRG will be defined as grades 1 and 2, and unfavorable mrTRG as stages 3, 4 and 5
Measured: Through study completion, an average of 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start18 Feb 2021
- Primary completion31 May 2022
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Rouanet, MD, Study chair, Institut Régional du Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224779
- Sponsor's protocol ID
- PROICM 2019-04 LIM
- Acronym
- LIMA
- Status last verified
- Feb 2025
- First submitted
- 8 Jan 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsies and IMAging for Improved Cancer Care - Non Metastatic Rectal Cancer
- ClinicalTrials.gov ID
- NCT04224779
- Acronym / sponsor ID
- LIMA / PROICM 2019-04 LIM
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Jan 2020 (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.
The recently developed liquid biopsy technology (to obtain and characterize tumour cells and tumour components like Deoxyribonucleic acid (DNA) or Ribonucleic Acid (RNA) from a simple blood draw), in combination with advanced Magnetic Resonance Imaging techniques (MRI), can tackle the following problems in rectal cancer: 1. Assessment of tumour heterogeneity from liquid biopsies. 2. Assessment from advanced MRI feature extraction to indicate poor outcome 3. Faster assessment of therapy response in Neoadjuvant chemotherapy (NAT) for rectal cancer; 4. Detection of emerging drug/therapy resistance. This project's overall objective is to develop and validate technologies and tools to include liquid biopsies in the clinical workflow, aiming at introducing a more precise and dynamic genetic characterization of tumour at the diagnosis and during treatment phases.
Detailed description
According to the Global cancer observatory database (Globocan) estimates, there are 447,136 new cases of Colo-Rectal Cancer (CRC) in Europe annually. This makes CRC the 2nd most common cancer in Europe, accounting for 13.0% of all cancers in 2012 with an estimate of 214,866 deaths from CRC in Europe (12.2% of the total number of cancer deaths, 2nd most common cause of cancer related deaths). In LIMA, the rectal cancer patient sub-group of CRC will be studied, comprising some 80,000 patients annually, as these patients are treated in neoadjuvant setting. Moreover, ineffective NeoAdjuvant Treatment (NAT) in rectal cancer patients will results in surgery with severe side effect, making stratification of patients according to their Neoadjuvant Chemotherapy (NAT) response a real challenge for this pathology.
Cancer is a very heterogeneous disease characterized by high variability of response to therapy. In general, it is unknown which cancers will respond to a certain therapy and which will not. Overall trend is to come to less invasive and more personalized treatment. Personalized medicine for cancer patients aims to tailor the best treatment options for the individual at diagnosis and during treatment. This requires accurate patient stratification based on molecular profiling of the tumour and its heterogeneity, not only at the first diagnosis but during the whole treatment. Treatment of cancer is associated with significant comorbidity and reduced quality of life, especially when an organ like the rectum, would need to be surgically removed to increase chances of curation of the disease. But also side-effects of treatment are important to consider. In the past decade the use of NAT has emerged as an effective therapeutic approach to reduce tumour volume and aggressiveness prior to surgery, resulting in increased chances at curative resection and saving the organ and to test sensitivity of a tumour to a therapy that will be used in adjuvant setting following surgery. The development of drugs that target tumour driving signal transduction pathways provides a very effective set of new cancer drugs to choose from in the neoadjuvant or adjuvant setting. This is based however on the premise that the tumour driving pathway is accurately defined in the tumour tissue and the appropriate targeted drug is selected. Using these drugs requires a personalized approach with careful matching of patient to drug therapy. In the neoadjuvant setting this poses a challenge, since tumours can be heterogenic with respect to the tumour driving signalling pathways, especially when high grade and larger sized. In such a case, multiple biopsies would need to be taken to enable accurate characterization of the whole tumour. Unfortunately this is often not feasible, while recent insights suggest that resulting inflammation of the tumour microenvironment may contribute to a more aggressive behaviour of the cancer cells. Another challenge in neoadjuvant treatment is early assessment of therapy response, to enable timely switching to another, more effective therapy in case of a non-response. In addition, in the case of use of targeted drugs, emerging resistance can be a problem, which should be detected as soon as possible. Aim of this project is to improve monitoring of patients' response at the diagnosis and during neoadjuvant treatment, to stratify the good and poor responders to Neoadjuvant chemotherapy (NAT), earlier and better than is currently possible.
The recently developed liquid biopsy technology (to obtain and characterize tumour cells and tumour components like Deoxyribonucleic Acid (DNA) or Ribonucleic Acid (RNA) from a simple blood draw), in combination with advanced Magnetic Resonance Imaging techniques (MRI), can tackle the following problems: 1. Assessment of tumour heterogeneity from liquid biopsies. 2. Assessment from advanced MRI feature extraction to indicate poor outcome 3. Faster assessment of therapy response in NAT for rectal cancer; 4. Detection of emerging drug/therapy resistance. This project overall objective is to develop and validate technologies and tools to include liquid biopsies in the clinical workflow, aiming at introducing a more precise and dynamic genetic characterization of tumour at the diagnosis and during treatment phases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumors and blood collection | Experimental | Biological: Biological collectionFor all the patients included in the study : * Blood samples will be collected at different times T1 (Baseline), T2 (1 or 2 weeks after the beginning of the treatment), T3 (3 or 4 weeks before the surgery) and T4 (1 month after the surgery). * Tumors biopsy will be collected for some patients who will benefit from an initial biopsy in the course of his management care in our Institute (before the surgery). In parallel to this biological collection, imaging and clinical data will be entered into a database treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old
- Histologically-confirmed diagnosis of adenocarcinoma of the rectum
- Distal part of the tumour within 2 to 12 cm of the anal margin
- Candidate for Neoadjuvant chemotherapy (NAT)
- Measurable disease (using the Recist criteria v1.1)
Key exclusion criteria (9 listed)
- Patient with metastatic disease
- Symptomatic cardiac or coronary insufficiency
- Severe renal insufficiency
- Progressive active infection or any other severe medical condition
- Other cancer treated within the last 5 years except in situ cervical carcinoma or basocellular/ spinocellular carcinoma
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 |
|---|---|---|
| Biological collectionThe biological collection will include samples of blood samples collected at different times but also tumoral biopsy before the surgery. | Biological | Tumors and blood collection |
Primary outcome
Area under the Receiver Operating Characteristic (ROC) curve of total cfDNA (defined as circulating cell-free DNA in plasma) percent change between the baseline sample (T1) and the sample at the end of the neo-adjuvant treatment (T3)
Time frame: Through study completion, an average of 3.5 years
This change of circulating free DeoxyriboNucleic Acid (cfDNA) percent will be correlated with the pathological complete response (defined as Grade 3 and 4 of Dworak definition) to neo-adjuvant treatment Pathological response (at surgery) is defined as Dworak definition below: * No regression (0), * Predominantly tumour with significant fibrosis and/or vasculopathy (1), * Predominantly fibrosis with scattered tumour cells (slightly recognizable histologically) (2), * Only scattered tumour cells in the space of fibrosis with / without acellular mucin (3) * No vital tumour cells detectable (4).
12 secondary outcomes
Area under the Receiver Operating Characteristic (ROC) curve of the total cfDNA percent change between the baseline sample (T1) and the first sample during the neo-adjuvant treatment (T2)
Time frame: Through study completion, an average of 3.5 years
Area under the Receiver Operating Characteristic (ROC) curve of the mutant cfDNA percent change between the baseline sample (T1) and the first sample during the neo-adjuvant treatment (T2) [resp the sample at the end of neo-adjuvant treatment (T3)]
Time frame: Through study completion, an average of 3.5 years
Number of Circulating tumor cells (CTCs) found in blood
Time frame: Through study completion, an average of 3.5 years
Tumoral response assessed by Magnetic resonance Imaging (MRI)
Time frame: Through study completion, an average of 3.5 years
Response to treatment by using a radiomics algorythm
Time frame: Through study completion, an average of 3.5 years
Sensibility (Se) of the total cfDNA percent change and the mutant cfDNA percent change
Time frame: Through study completion, an average of 3.5 years
Specificity (Se) of the total cfDNA percent change and the mutant cfDNA percent change
Time frame: Through study completion, an average of 3.5 years
Predictive Positive Value (PPV) of the total cfDNA percent change and the mutant cfDNA percent change
Time frame: Through study completion, an average of 3.5 years
Predictive Negative Value (PNV) of the total cfDNA percent change and the mutant cfDNA percent change
Time frame: Through study completion, an average of 3.5 years
The number of molecular signal transduction pathway that appear in addition to the wingless integration site (Wnt) pathway at T1, T2, T3 and T4
Time frame: Through study completion, an average of 3.5 years
Tumoral response assessed by Magnetic resonance Imaging (MRI)
Time frame: Through study completion, an average of 3.5 years
Tumoral response assessed by Magnetic resonance Imaging (MRI)
Time frame: Through study completion, an average of 3.5 years
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 12 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Philippe Rouanet, MD study chair
Institut Régional du Cancer de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological collection in people with Rectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 10 inclusion and 9 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 12 Feb 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 France. 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?
Area under the Receiver Operating Characteristic (ROC) curve of total cfDNA (defined as circulating cell-free DNA in plasma) percent change between the baseline sample (T1) and the sample at the end of the neo-adjuvant treatment (T3) (time frame: Through study completion, an average of 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.