AngiogenesisNCT04851054
Postoperative VEGF and Recurrence After Colon Cancer Surgery
An observational study of Angiogenesis and Colon Cancer, run by Hospital del Mar.
Trial summary
The purpose of this trial is to study the relationship between the angiogenic response to surgical aggression, determined through the serum levels of vascular endothelial growth factor (VEGF) on postoperative day four, and the tumor recurrence in patients with colon cancer operated with a curative intention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiogenesis, Colon Cancer, Surgery
- What is being tested?
- Surgery for colon cancer with intention to cure
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2021
- How long will I take part?
- 2 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 colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study, who will undergo elective surgical resection with potentially curative intention.
Who may be able to join
- Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study,
- Patients who will undergo elective surgical resection with potentially curative intention
Who cannot join
- Patients with metastatic disease
- Patients with synchronous colon neoplasia or in the previous five years
- Patients undergoing emergency surgery
- Patients who do not sign the informed consent.
About this study
Official title: Postoperative Serum VEGF Concentration as an Independent Prognostic Factor for Recurrence After Curative Colon Cancer Surgery. Multicentric Study.
The purpose of this trial is to study the relationship between the angiogenic response to surgical aggression, determined through the serum levels of vascular endothelial growth factor (VEGF) on postoperative day four, and the tumor recurrence in patients with colon cancer operated with a curative intention.
Read the detailed description
DESIGN: Prospective multicentric study.
PARTICIPATION: Colorectal Surgery Units of Hospital del Mar, Barcelona; Hospital Universitari Joan XXIII, Tarragona; Hospital Universitari La Fe, Valencia; Hospital Clínico San Carlos, Madrid; Hospital General de Granollers, Granollers; Hospital Germans Trias i Pujol, Badalona; Athalaia, Xarxa Assistencial Universitària de Manresa, Manresa
STUDY SUBJECTS: 280 consecutive patients with non-metastatic colon cancer in whom a curative intent resection is performed.
DETERMINATIONS: Determination of the proangiogenic cytokine VEGF in serum on the postoperative day four to assess its relationship with oncological results on long-term follow-up.
- Conditions
- Angiogenesis, Colon Cancer, Surgery, Recurrence, VEGF Overexpression
- Being tested
- Surgery for colon cancer with intention to cure
- Keywords
- VEGF, Colon Cancer, Surgery, Recurrence
- Medical subject headings
- Colonic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for colon cancer with intention to cureProcedure or surgery
Surgery by open or laparoscopic approach
| Study group | Role | What they receive |
|---|---|---|
| Patients after surgery for colon cancer with intention to cure | Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study, who will undergo elective surgical resection with potentially curative intention Receives: Procedure: Surgery for colon cancer with intention to cure |
What is being measured
The primary outcome is the main question the study is designed to answer.
VEGF in serum on postop day 4
A 10cc sample of peripheral blood will be drawn on postoperative day 4
Measured: Postoperative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Jan 2017
- Primary completion30 Mar 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngiogenesisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Hospital de Granollers, Althaia Xarxa Assistencial Universitària de Manresa, Hospital Universitari Joan XXIII de Tarragona.
- Responsible party
- Principal investigator, Marta Pascual, Hospital del Mar
- Investigators
- MIGUEL PERA, PhD, Study chair, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851054
- Sponsor's protocol ID
- 2015/6097/I
- Status last verified
- Apr 2021
- First submitted
- 11 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Serum VEGF Concentration as an Independent Prognostic Factor for Recurrence After Curative Colon Cancer Surgery. Multicentric Study.
- ClinicalTrials.gov ID
- NCT04851054
- Acronym / sponsor ID
- 2015/6097/I
- Conditions
- Angiogenesis, Colon Cancer, Surgery, Recurrence, VEGF Overexpression
- Keywords
- VEGF, Colon Cancer, Surgery, Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Hospital de Granollers, Althaia Xarxa Assistencial Universitària de Manresa, Hospital Universitari Joan XXIII de Tarragona.
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Apr 2021 (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 purpose of this trial is to study the relationship between the angiogenic response to surgical aggression, determined through the serum levels of vascular endothelial growth factor (VEGF) on postoperative day four, and the tumor recurrence in patients with colon cancer operated with a curative intention.
Detailed description
DESIGN: Prospective multicentric study.
PARTICIPATION: Colorectal Surgery Units of Hospital del Mar, Barcelona; Hospital Universitari Joan XXIII, Tarragona; Hospital Universitari La Fe, Valencia; Hospital Clínico San Carlos, Madrid; Hospital General de Granollers, Granollers; Hospital Germans Trias i Pujol, Badalona; Athalaia, Xarxa Assistencial Universitària de Manresa, Manresa
STUDY SUBJECTS: 280 consecutive patients with non-metastatic colon cancer in whom a curative intent resection is performed.
DETERMINATIONS: Determination of the proangiogenic cytokine VEGF in serum on the postoperative day four to assess its relationship with oncological results on long-term follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after surgery for colon cancer with intention to cure | – | Procedure: Surgery for colon cancer with intention to curePatients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study, who will undergo elective surgical resection with potentially curative intention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study, who will undergo elective surgical resection with potentially curative intention.
Key inclusion criteria (2 listed)
- Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study,
- Patients who will undergo elective surgical resection with potentially curative intention
Key exclusion criteria (4 listed)
- Patients with metastatic disease
- Patients with synchronous colon neoplasia or in the previous five years
- Patients undergoing emergency surgery
- Patients who do not sign the informed consent.
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 |
|---|---|---|
| Surgery for colon cancer with intention to cureSurgery by open or laparoscopic approach | Procedure or surgery | Patients after surgery for colon cancer with intention to cure |
Primary outcome
VEGF in serum on postop day 4
Time frame: Postoperative day 4
A 10cc sample of peripheral blood will be drawn on postoperative day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Angiogenesis
Not yet recruitingPhase 2
Study of Suvemcitug Plus Chemotherapy in Advanced High-Grade Serous Ovarian Cancer
High-grade Serous Ovarian Cancer
Not yet recruitingPhase 2
First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma
Peritoneal Mesothelioma, First-line Therapy
RecruitingPhase 1/2
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced / Metastatic Solid Tumors
RecruitingPhase 1/2
Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
Kaposi Sarcoma
Active, not recruiting
Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents
Kidney Cancer
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.
MIGUEL PERA, PhD study chair
Hospital del Mar
Questions about this trial
What is this clinical trial studying?
An observational study of Angiogenesis and Colon Cancer, run by Hospital del Mar.
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 2 inclusion and 4 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
VEGF in serum on postop day 4 (time frame: Postoperative day 4). 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 20 Apr 2021.