Metastatic Colorectal CancerNCT01693848
"Cancersensor" Metastasis Resection
An observational study of Metastatic Colorectal Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Nov 2014
- 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 metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital
Who may be able to join
- Histologically-confirmed metastatic colorectal cancer;
- 0 to 3 prior chemotherapy lines; Signed informed consent;
- Good understanding of the protocol and of the follow-up;
- Estimated life expectancy exceeding 3 months;
- At least one measurable metastatic lesion (RECIST criteria);
- Performance Status (WHO) of 0 to 2;
- Good haematological, hepatic and renal functions.
Who cannot join
- Poor haematological, hepatic or renal functions;
- Uncontrolled chronic disease;
- Serious unhealed wound, ulcer or fracture within the previous month;
- Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
- Pregnancy or breast-feeding during the previous month;
- Transmeridian trip of more than 4 time zones within the prior 2 weeks;
- Person with legal restriction to participate into clinical research, according to the current law in France.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring, of Cancer Therapy: Impact of Surgical Resection of Metastasis on Urinary Excretion of Modified Nucleosides.
Observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal, Cancer, Metastatic, Control, Urine, Nucleosides, Surgery, General anesthesia, Scheduled for surgery
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with metastatic colorectal cancer scheduled for metastatic surgery | |
| Control patients | Patients with metastatic colorectal cancer scheduled for general anesthesia without metastatic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of resection of metastasis on urinary excretion of modified nucleosides
1 Urine sample per day 3 before and 7 after surgery Measurement of modified nucleoside concentration
Measured: 10 days
Secondary outcomes (1)
Identification of modified nucleosides as biomarkers for colorectal cancer
Measurement of modified nucleosides in urine samples before and after metastatic resection
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693848
- Sponsor's protocol ID
- C11-58
- Other IDs
- 2012-A00011-42
- Status last verified
- Dec 2016
- First submitted
- 7 Sep 2012
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring, of Cancer Therapy: Impact of Surgical Resection of Metastasis on Urinary Excretion of Modified Nucleosides.
- ClinicalTrials.gov ID
- NCT01693848
- Acronym / sponsor ID
- C11-58
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal, Cancer, Metastatic, Control, Urine, Nucleosides, Surgery, General anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Sep 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Sep 2012 (estimated)
- 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.
Observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with metastatic colorectal cancer scheduled for metastatic surgery |
| Control patients | – | –Patients with metastatic colorectal cancer scheduled for general anesthesia without metastatic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital
Key inclusion criteria (7 listed)
- Histologically-confirmed metastatic colorectal cancer;
- 0 to 3 prior chemotherapy lines; Signed informed consent;
- Good understanding of the protocol and of the follow-up;
- Estimated life expectancy exceeding 3 months;
- At least one measurable metastatic lesion (RECIST criteria);
Key exclusion criteria (7 listed)
- Poor haematological, hepatic or renal functions;
- Uncontrolled chronic disease;
- Serious unhealed wound, ulcer or fracture within the previous month;
- Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
- Pregnancy or breast-feeding during the previous month;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of resection of metastasis on urinary excretion of modified nucleosides
Time frame: 10 days
1 Urine sample per day 3 before and 7 after surgery Measurement of modified nucleoside concentration
1 secondary outcome
Identification of modified nucleosides as biomarkers for colorectal cancer
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metastatic Colorectal Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 7 Dec 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of resection of metastasis on urinary excretion of modified nucleosides (time frame: 10 days). 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 7 Dec 2016.