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Colon CancerNCT02789709

Metabolomic Phenotyping After Surgery for Colon Cancer: Study of Novel Predictive Biomarkers

An observational study of Colon Cancer, run by Parc de Salut Mar at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Predictive biomarkers are needed to identify those patients with higher risk of recurrence after surgery for colon cancer with curative intent. Our main objective is to determine a metabolite profile in blood plasma from patients operated from colorectal cancer that can be associated with the oncologic outcome and be… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer
What is being tested?
Surgery
Type of treatment
Surgery or procedure
How many people
130 participants
Where
1 siteSpain
Study dates
Jan 2016to Dec 2019
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: Consecutive patients undergoing surgery for colon and rectal cancer with curative intent

Who may be able to join

  • Non-metastatic colon and rectal cancer undergoing surgery with curative intent
  • Patients signed informed consent

Who cannot join

  • Patients undergoing preoperative chemotherapy and/or radiotherapy
  • Emergency surgery
  • Surgical resection R1 or R2
  • Patients presenting with other known malignancies for which they are receiving treatment

Trial locations and contacts

1 site in 1 country.

Spain1 site, 1 recruiting

  • Hospital del Mar Medical Research Institute

    Barcelona, Barcelona, 08003

    Miguel Pera, MDPhD, 34932483207, mpera@hospitaldelmar.cat

    Marta Pascual, MDPhD, 34932483207, mpascual@hospitaldelmar.cat

    Recruiting

Other trials in Spain

About this study

Predictive biomarkers are needed to identify those patients with higher risk of recurrence after surgery for colon cancer with curative intent. Our main objective is to determine a metabolite profile in blood plasma from patients operated from colorectal cancer that can be associated with the oncologic outcome and be validated as predictive biomarkers in future studies. A secondary objective is to study the glycolytic metabolism of colon cancer cell lines treated with plasma samples from the same patients. In particular, to validate the increased utilization of lactate by tumor cells as a metabolic substrate using postoperative human samples.

Patients with colorectal cancer that have undergone surgical resection will be included. Plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and 18th months after surgery. Metabolic profiles in plasma samples will be determined using a kit that allows the quantification of 180 metabolites by mass spectrometry.

A clinical follow up will be maintained for at least 2 years to identify tumor recurrences.

Read the detailed description

Up to 30-40% of patients operated from colorectal cancer display tumor recurrence. Predictive biomarkers are needed to identify those patients with higher risk of recurrence. Our main objective is to determine a metabolite profile in blood plasma from patients operated from colorectal cancer that can be associated with the oncologic outcome and be validated as prognostic biomarkers in future studies. A secondary objective is to study the glycolytic metabolism of colon cancer cell lines treated with plasma samples from the same patients. In particular, to validate the increased utilization of lactate by tumor cells as a metabolic substrate using postoperative human samples, as it was previously observed by us in vitro using an inflammatory environment in conditions of hypoxia and lack of glucose. Patients with colorectal cancer that have undergone surgical resection will be included. Plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and 18th months after surgery. Metabolic profiles in plasma samples will be determined using a kit that allows the quantification of 180 metabolites by mass spectrometry. Cellular assays will be performed on the SW620 and HT-29 colon cancer cell lines. Cells will be treated with plasma samples and the concentration of lactate and other metabolites will be analyzed in the medium supernatants. A clinical follow up will be maintained for at least 2 years to identify tumor recurrences.

Conditions
Colon Cancer
Being tested
Surgery
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Segmental resection for colon cancer and anterior resection in patients with rectal cancer

Study groups in NCT02789709
Study groupRoleWhat they receive
Non metastatic colon cancer patientsConsecutive patients undergoing elective surgery for non-metastatic colon or rectal cancer with curative intent.
Receives: Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    Time from the date of surgery to the date of first documentation of recurrence

    Measured: 5 years from the date of surgery

Secondary outcomes (5)

  1. Disease-specific survival

    Time from the date of surgery to death by colon cancer

    Measured: 5 years from the date of surgery

  2. Local recurrence

    Tumor associated with surgical site (anastomosis, tumor bed, and mesentery) and confirmed histologically or by imaging.

    Measured: 5 years from the date of surgery

  3. Systemic recurrence

    Spread of the disease outside the surgical field to organs such as the liver, lungs, bones, or brain

    Measured: 5 years from the date of surgery

  4. Postoperative intra-abdominal sepsis

    Anastomotic leak or intra-abdominal abscess

    Measured: 30 days from the date of surgery

  5. Postoperative mortality

    Measured: 30 days from the date of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02789709
Sponsor's protocol ID
PI15/00458
Status last verified
May 2016
First submitted
30 May 2016
Last updated
3 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Pera M, Nelson H, Rajkumar SV, Young-Fadok TM, Burgart LJ. Influence of postoperative acute-phase response on angiogenesis and tumor growth: open vs. laparoscopic-assisted surgery in mice. J Gastrointest Surg. 2003 Sep-Oct;7(6):783-90. doi: 10.1016/s1091-255x(03)00111-2.

    PubMed 13129557

  • Bohle B, Pera M, Pascual M, Alonso S, Mayol X, Salvado M, Schmidt J, Grande L. Postoperative intra-abdominal infection increases angiogenesis and tumor recurrence after surgical excision of colon cancer in mice. Surgery. 2010 Jan;147(1):120-6. doi: 10.1016/j.surg.2009.06.035. Epub 2009 Sep 20.

    PubMed 19767043

  • Pascual M, Alonso S, Pares D, Courtier R, Gil MJ, Grande L, Pera M. Randomized clinical trial comparing inflammatory and angiogenic response after open versus laparoscopic curative resection for colonic cancer. Br J Surg. 2011 Jan;98(1):50-9. doi: 10.1002/bjs.7258. Epub 2010 Aug 26.

    PubMed 20799296

  • Pascual M, Bohle B, Alonso S, Mayol X, Salvans S, Grande L, Pera M. Preoperative administration of erythropoietin stimulates tumor recurrence after surgical excision of colon cancer in mice by a vascular endothelial growth factor-independent mechanism. J Surg Res. 2013 Jul;183(1):270-7. doi: 10.1016/j.jss.2012.12.041. Epub 2013 Jan 16.

    PubMed 23348072

  • Salvans S, Mayol X, Alonso S, Messeguer R, Pascual M, Mojal S, Grande L, Pera M. Postoperative peritoneal infection enhances migration and invasion capacities of tumor cells in vitro: an insight into the association between anastomotic leak and recurrence after surgery for colorectal cancer. Ann Surg. 2014 Nov;260(5):939-43; discussion 943-4. doi: 10.1097/SLA.0000000000000958.

    PubMed 25243554

  • Espin E, Ciga MA, Pera M, Ortiz H; Spanish Rectal Cancer Project. Oncological outcome following anastomotic leak in rectal surgery. Br J Surg. 2015 Mar;102(4):416-22. doi: 10.1002/bjs.9748. Epub 2015 Jan 26.

    PubMed 25619499

  • Alonso S, Pascual M, Salvans S, Mayol X, Mojal S, Gil MJ, Grande L, Pera M. Postoperative intra-abdominal infection and colorectal cancer recurrence: a prospective matched cohort study of inflammatory and angiogenic responses as mechanisms involved in this association. Eur J Surg Oncol. 2015 Feb;41(2):208-14. doi: 10.1016/j.ejso.2014.10.052. Epub 2014 Nov 1.

    PubMed 25468742

  • Montcusi B, Madrid-Gambin F, Pozo OJ, Marco S, Marin S, Mayol X, Pascual M, Alonso S, Salvans S, Jimenez-Toscano M, Cascante M, Pera M. Circulating metabolic markers after surgery identify patients at risk for severe postoperative complications: a prospective cohort study in colorectal cancer. Int J Surg. 2024 Mar 1;110(3):1493-1501. doi: 10.1097/JS9.0000000000000965.

    PubMed 38116682

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Cancer, run by Parc de Salut Mar 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 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 3 Jun 2016. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 5 years from the date of surgery). 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 NCT02789709, which also lists 8 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 3 Jun 2016.

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