Colorectal CancerVEGF-GCNCT04145505
Micrometastases and Angiogenesis in Colon Cancer. Prognostic Value of VEGF.
An observational study of Colorectal Cancer and Angiogenesis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
According to current clinical guidelines adjuvant treatment in colon cancer is not recommended in patients with stage I and IIA, and in patients with high risk factors (IIB) adjuvant treatment has not shown a clear benefit in recurrence or survival. However, more than 20% of these patients have recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Angiogenesis
- What is being tested?
- COLORECTAL CANCER SURGERY
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2019to 21 Feb 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with colonic cancer and curative surgery
Who may be able to join
- Patients older than 18 years
- Diagnosis of colon adenocarcinoma located above promontory
- Elective surgical treatment with oncological criteria and curative intention
Who cannot join
- Non-acceptance by the patient
- Patients who have received QT during the preoperative period
- Patients with previous colon surgery
- Patients with definitive study of the surgical piece with involvement of the lymph nodes according to conventional histological study (Stage III)
- Patients presenting distant dissemination in the extension study (Stage IV)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Maria Carmen Balagué Ponz, MD, +34 93 556 56 71, cbalague@santpau.cat
Eduardo Maria Targarona Soler, MD PhD, +34 93 556 56 71, etargarona@santpau.cat
About this study
Official title: Influence of the Presence of Ganglionar Micrometastases Associated With an Elevation of Angiogenesis on the Evolution of Colon Cancer. Prognostic Value of the Levels of VEGF-A Anf VEGF-C
According to current clinical guidelines adjuvant treatment in colon cancer is not recommended in patients with stage I and IIA, and in patients with high risk factors (IIB) adjuvant treatment has not shown a clear benefit in recurrence or survival.
However, more than 20% of these patients have recurrence. This high percentage raises the possible understaging of current methods, so in recent years different methods have been developed in order to obtain a correct staging that have allowed a greater detection of micrometastasis (less than 2mm).
Read more
The performance of the detection technique of the sentinel node in colon cancer allows us to perform this study in 1-3 lymph nodes, so that performing in all the nodes removed in a piece would be imposible in daily clinical practice for time, personnel and economic resources needed to do it.
This technique achieves between 5-15% of overstaging which means that in stages I and IIA can lead to a change in the indication of adjuvant treatment. Despite this, the influence of ganglion micrometastases on survival is still controversial. This leads to consider other factors that may influence tumor aggressiveness, such as an increase in angiogenesis that allows the viability of implants less than 2mm. Therefore, we propose that elevated levels of VEGF (angiogenesis marker) in patients with sentinel lymph node micrometastases can lead to a worse prognosis.
Based on these premises, the aim of the study is to assess the correlation between the levels of serum and tumor VEGF-A and VEGF-C (markers of angiogenesis and lymphangiogenesis) and the evolution of the disease in patients with lymph node micrometastases.
Read the detailed description
Once the investigators have all the data of the patients included in the study, and the ELISA analysis of the serum and tissue VEGF levels has been performed, we hope to determine a threshold level of VEGF in blood and tissue that modifies the prognostic implications of the presence of ganglionic micrometastasis, which increases the viability of these implants.
If the investigators determine this threshold and demonstrate that high levels of this molecule, both in blood and tissue, increase the rate of recurrence in patients with lymph node micrometastases, would be suggested a change in the indications for adjuvant treatment in patients in whom it is not currently indicated (stages I-IIA and IIB without other factors of poor prognosis) considering that they have an independent bad prognostic factor such as a high level (above our threshold) of VEGF. This allows the investigators to select those patients who would benefit from chemotherapy treatment despite not being indicated according to the current treatment guidelines (NCCN 2018).
- Conditions
- Colorectal Cancer, Angiogenesis
- Being tested
- COLORECTAL CANCER SURGERY
- Keywords
- SENTINEL NODE
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLORECTAL CANCER SURGERYProcedure or surgery
SENTINEL NODE DETECTION
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
local, lymph node or distant mtastasis appearance
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start26 Oct 2019
- Primary completion21 Feb 2020 (estimated)
- Study completion21 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Carmen Balague Ponz, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Investigators
- CARMEN BALAGUÉ PONS, PHD DR, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145505
- Sponsor's protocol ID
- IIBSP-VEG-2018-77
- Acronym
- VEGF-GC
- Status last verified
- Oct 2019
- First submitted
- 26 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- 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 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Presence of Ganglionar Micrometastases Associated With an Elevation of Angiogenesis on the Evolution of Colon Cancer. Prognostic Value of the Levels of VEGF-A Anf VEGF-C
- ClinicalTrials.gov ID
- NCT04145505
- Acronym / sponsor ID
- VEGF-GC / IIBSP-VEG-2018-77
- Conditions
- Colorectal Cancer, Angiogenesis
- Keywords
- SENTINEL NODE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 26 Oct 2019 (actual)
- Primary completion
- 21 Feb 2020 (estimated)
- Study completion
- 21 Feb 2021 (estimated)
- First posted
- 30 Oct 2019 (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.
According to current clinical guidelines adjuvant treatment in colon cancer is not recommended in patients with stage I and IIA, and in patients with high risk factors (IIB) adjuvant treatment has not shown a clear benefit in recurrence or survival.
However, more than 20% of these patients have recurrence. This high percentage raises the possible understaging of current methods, so in recent years different methods have been developed in order to obtain a correct staging that have allowed a greater detection of micrometastasis (less than 2mm).
The performance of the detection technique of the sentinel node in colon cancer allows us to perform this study in 1-3 lymph nodes, so that performing in all the nodes removed in a piece would be imposible in daily clinical practice for time, personnel and economic resources needed to do it.
This technique achieves between 5-15% of overstaging which means that in stages I and IIA can lead to a change in the indication of adjuvant treatment. Despite this, the influence of ganglion micrometastases on survival is still controversial. This leads to consider other factors that may influence tumor aggressiveness, such as an increase in angiogenesis that allows the viability of implants less than 2mm. Therefore, we propose that elevated levels of VEGF (angiogenesis marker) in patients with sentinel lymph node micrometastases can lead to a worse prognosis.
Based on these premises, the aim of the study is to assess the correlation between the levels of serum and tumor VEGF-A and VEGF-C (markers of angiogenesis and lymphangiogenesis) and the evolution of the disease in patients with lymph node micrometastases.
Detailed description
Once the investigators have all the data of the patients included in the study, and the ELISA analysis of the serum and tissue VEGF levels has been performed, we hope to determine a threshold level of VEGF in blood and tissue that modifies the prognostic implications of the presence of ganglionic micrometastasis, which increases the viability of these implants.
If the investigators determine this threshold and demonstrate that high levels of this molecule, both in blood and tissue, increase the rate of recurrence in patients with lymph node micrometastases, would be suggested a change in the indications for adjuvant treatment in patients in whom it is not currently indicated (stages I-IIA and IIB without other factors of poor prognosis) considering that they have an independent bad prognostic factor such as a high level (above our threshold) of VEGF. This allows the investigators to select those patients who would benefit from chemotherapy treatment despite not being indicated according to the current treatment guidelines (NCCN 2018).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with colonic cancer and curative surgery
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Diagnosis of colon adenocarcinoma located above promontory
- Elective surgical treatment with oncological criteria and curative intention
Key exclusion criteria (5 listed)
- Non-acceptance by the patient
- Patients who have received QT during the preoperative period
- Patients with previous colon surgery
- Patients with definitive study of the surgical piece with involvement of the lymph nodes according to conventional histological study (Stage III)
- Patients presenting distant dissemination in the extension study (Stage IV)
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 |
|---|---|---|
| COLORECTAL CANCER SURGERYSENTINEL NODE DETECTION | Procedure or surgery | – |
Primary outcome
recurrence
Time frame: 5 years
local, lymph node or distant mtastasis appearance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- 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.
CARMEN BALAGUÉ PONS, PHD DR principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Colorectal Cancer and Angiogenesis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Oct 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IRENE GÓMEZ TORRES, PHD (+34 678309987, irenegomeztorres@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: 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 30 Oct 2019.