Solid Tumor, AdultCTC-CEC-ADNNCT02220556
Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology
A study testing Blood sampling in people with Solid Tumor, Adult, run by Institut Curie at 3 sites in France.
Trial summary
Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral type. Up to 50 patient can be included into each cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2010to Jun 2018
- Phase
- Interventional
- 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
Who may be able to join
- 18 years old or more
- Performance status from 0 to 4
- Patient treated followed for histologically confirmed solid tumor type of any of these localization : breast, prostate, uterus, ovary, colon, lung, head and neck, melanoma.
- Informed consent form signed.
Who cannot join
- Patient with history of other invasive cancer within 5 years.
- Patient treated for any non-invasive cancer
- Patient individually deprived of liberty or placed under the authority of a tutor
- Geographical condition potentially preventing compliance with the study protocol.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Curie
Paris, 75005
Institut Mutualiste Montsouris
Paris, 75014
Institut Curie
Saint-Cloud, 92210
About this study
Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral type. Up to 50 patient can be included into each cohort.
- Conditions
- Solid Tumor, Adult
- Being tested
- Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
CTC, CEC or ctDNA incidence
number of CTC or CEC in 7.5ml of blood
Measured: 3 years
Secondary outcomes (2)
CTC and CEC molecular characterization
This outcome is self-explanatory.
Measured: 3 years
Circulating tumor DNA (ctDNA) detection and quantification
plasma mutation detection (number of copy)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startDec 2010
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves Pierga, Prof., Principal investigator, Institut CurieFrançois-Clément Bidard, MD, PhD, Study chair, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220556
- Sponsor's protocol ID
- IC 2010-01
- Acronym
- CTC-CEC-ADN
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2014
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Cabel L, Jeannot E, Bieche I, Vacher S, Callens C, Bazire L, Morel A, Bernard-Tessier A, Chemlali W, Schnitzler A, Lievre A, Otz J, Minsat M, Vincent-Salomon A, Pierga JY, Buecher B, Mariani P, Proudhon C, Bidard FC, Cacheux W. Prognostic Impact of Residual HPV ctDNA Detection after Chemoradiotherapy for Anal Squamous Cell Carcinoma. Clin Cancer Res. 2018 Nov 15;24(22):5767-5771. doi: 10.1158/1078-0432.CCR-18-0922. Epub 2018 Jul 27.
PubMed 30054279Cabel L, Decraene C, Bieche I, Pierga JY, Bennamoun M, Fuks D, Ferraz JM, Lefevre M, Baulande S, Bernard V, Vacher S, Mariani P, Proudhon C, Bidard FC, Louvet C. Limited Sensitivity of Circulating Tumor DNA Detection by Droplet Digital PCR in Non-Metastatic Operable Gastric Cancer Patients. Cancers (Basel). 2019 Mar 21;11(3):396. doi: 10.3390/cancers11030396.
PubMed 30901876
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology
- ClinicalTrials.gov ID
- NCT02220556
- Acronym / sponsor ID
- CTC-CEC-ADN / IC 2010-01
- Conditions
- Solid Tumor, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 20 Aug 2014 (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.
Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral type. Up to 50 patient can be included into each cohort.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or more
- Performance status from 0 to 4
- Patient treated followed for histologically confirmed solid tumor type of any of these localization : breast, prostate, uterus, ovary, colon, lung, head and neck, melanoma.
- Informed consent form signed.
Key exclusion criteria (4 listed)
- Patient with history of other invasive cancer within 5 years.
- Patient treated for any non-invasive cancer
- Patient individually deprived of liberty or placed under the authority of a tutor
- Geographical condition potentially preventing compliance with the study protocol.
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 |
|---|---|---|
| Blood sampling | Procedure or surgery | – |
Primary outcome
CTC, CEC or ctDNA incidence
Time frame: 3 years
number of CTC or CEC in 7.5ml of blood
2 secondary outcomes
CTC and CEC molecular characterization
Time frame: 3 years
Circulating tumor DNA (ctDNA) detection and quantification
Time frame: 3 years
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 8 Aug 2025.
- Background: PubMed 30054279Cabel L, Jeannot E, Bieche I, Vacher S, Callens C, Bazire L, Morel A, Bernard-Tessier A, Chemlali W, Schnitzler A, Lievre A, Otz J, Minsat M, Vincent-Salomon A, Pierga JY, Buecher B, Mariani P, Proudhon C, Bidard FC, Cacheux W. Prognostic Impact of Residual HPV ctDNA Detection after Chemoradiotherapy for Anal Squamous Cell Carcinoma. Clin Cancer Res. 2018 Nov 15;24(22):5767-5771. doi: 10.1158/1078-0432.CCR-18-0922. Epub 2018 Jul 27.
- Background: PubMed 30901876Cabel L, Decraene C, Bieche I, Pierga JY, Bennamoun M, Fuks D, Ferraz JM, Lefevre M, Baulande S, Bernard V, Vacher S, Mariani P, Proudhon C, Bidard FC, Louvet C. Limited Sensitivity of Circulating Tumor DNA Detection by Droplet Digital PCR in Non-Metastatic Operable Gastric Cancer Patients. Cancers (Basel). 2019 Mar 21;11(3):396. doi: 10.3390/cancers11030396.
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Solid Tumor
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.
Jean-Yves Pierga, Prof. principal investigator
Institut Curie
François-Clément Bidard, MD, PhD study chair
Institut Curie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Solid Tumor, Adult, run by Institut Curie at 3 sites 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 4 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: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
CTC, CEC or ctDNA incidence (time frame: 3 years). 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 NCT02220556, which also lists 2 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 8 Aug 2025.