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CarcinomaNCT01361100

Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract

A study testing Oncoral® test in people with Carcinoma, run by Centre Leon Berard at 8 sites in France.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study includes 2 steps. The first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. Patients will be enrolled before any treatment. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Carcinoma
What is being tested?
Oncoral® test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
485 participants
Where
8 sitesFrance
Study dates
Dec 2010to Jun 2015
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First step:
  • Man or woman aged more than 40 years
  • With frequent alcohol intoxication and/or smoking
  • With histologically confirmed epidermoid carcinoma of the upper aerodigestive tract
  • No treatment delivered for this disease
  • Signed, written informed consent
Show all 13Show fewer
  • Mandatory affiliation with a health insurance system
  • Second step:
  • Man or woman aged more than 40 years
  • With frequent alcohol intoxication and/or smoking
  • With no sign of an epidermoid carcinoma of the upper aerodigestive tract
  • Signed, written informed consent
  • Mandatory affiliation with a health insurance system

Who cannot join

  • First step:
  • Previous history of cancer except carcinoma in situ of the uterine cervix or skin basal cell carcinoma treated with curative intent
  • Gingivorrhagia when the test is realised
  • Hypersensitivity to aspirin or to benzoate
  • Asthmatic, diabetic patients or patents with chronic bronchitis requiring oxygen therapy
  • Patients taking antibiotics at enrolment or during the previous week
Show all 13Show fewer
  • Second step:
  • Previous history of cancer except carcinoma in situ of the uterine cervix or skin basal cell carcinoma treated with curative intent
  • Patient already treated for a cancer
  • Gingivorrhagia when the test is realised
  • Hypersensitivity to aspirin or to benzoate
  • Asthmatic, diabetic patients or patients with chronic bronchitis requiring oxygen therapy
  • Patients on antibiotics at enrolment or during the previous week

Trial locations and contacts

8 sites in 1 country.

Sophie DUSSART, MD contact

+33 478 78 27 52

sophie.dussart@lyon.unicancer.fr

Justine SEMAL contact

+33 478 78 29 22

justine.semal@lyon.unicancer.fr

8 sites in 1 country

France8 sites, 8 recruiting

  • CHU Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, 33076

    Erwan DE MONES DEL PUJOL, MD

    Alban PASQUIES, MD

    Recruiting

  • CHU Caen Cote de Nacre

    Caen, 14033

    Emmanuel BABIN, MD Ph.D

    Hervé BENATEAU, MD Ph.D

    Recruiting

  • Centre François Baclesse

    Caen, 14076

    Marie-Yolande LOUIS, MD

    Not yet recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Yann MALLET, MD

    Jean-Louis LEFEBVRE, MD Ph.D

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Philippe ZROUNBA, MD

    Didier GIRODET, MD

    Recruiting

  • Groupement Hospitalier Pitié Salpêtrière

    Paris, 75005

    Lofti BEN SLAMA, MD

    Not yet recruiting

  • Institut Curie

    Paris, 75005

    Angélique GIROD, MD

    Recruiting

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

    Gilles DOLIVET, MD

    Sophie CORTESE, MD

    Recruiting

Other trials in France

About this study

This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study includes 2 steps. The first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. Patients will be enrolled before any treatment. They will immediately undergo the test. No follow-up will be realized. In total, 100 patients will be included in this first step. The estimated period of inclusion is 6 months.

If the algorithm is validated, the second step of the study will start. The purpose is to determine the characteristics of the test. Enrollment will concern smokers and alcohol drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract. Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum of one year. In total, 385 patients will be enrolled in this step during an estimated period of 18 months.

Conditions
Carcinoma
Being tested
Oncoral® test
Keywords
Otolaryngology
Medical subject headings
Carcinoma

What participants receive

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

  • Oncoral® testDevice

    The patient rinses his oral cavity for 2 minutes. Then he screws lid back onto a beaker. The investigator holds the beaker straight so that the end of the aspiration mouth is dipped into the liquid. Then, the investigators takes 2 tubes and pushes them one after the other down on the opening of the beaker. The tubes should fill by themselves. The tubes can't be kept more than eleven days and are send to the Clinident Institute for the analysis.

Study groups in NCT01361100
Study groupRoleWhat they receive
Oncoral testExperimentalNot described
Receives: Device: Oncoral® test

What is being measured

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

  1. First step: Confirm that the parameters used for the development of the test to qualify it as positive or negative lead to the same level of sensitivity (98%)

    The algorithm was first defined when the test was developed in patients on different tumour stages .

    Measured: 1 year after the beginning of enrollment

  2. Second step: Determine the characteristics of the Oncoral® test

    Sensitivity, specificity, positive predictive value, negative predictive value.

    Measured: 2 years after the beginning of the second step enrolment

Secondary outcomes (3)

  1. First step: Estimation of test sensitivity

    Sensitivity will be assessed by the calculation : true positives / (true positives + false negatives)

    Measured: 1 year after the beginning of enrolment

  2. Second step : Estimation of test feasibility

    Feasibility will be assessed by :

    • the rate of patients who were not able to realise the test (difficulty to rinse the oral cavity)
    • the rate of tests that cannot be analysed (inadequate tests, problems of stability, difficulties with the extraction of volatile molecules, DNA or mRNA...) If the rate of unusable tests is greater than 10%, corrective actions will be necessary in order to use this test in the future. These actions will be considered according to the type of problems (adjustments of the test, transport...)

    Measured: 2 years after the beginning of the second step enrolment

  3. Second step: Estimation of the prevalence of epidermoid carcinoma of the upper aerodigestive tract in the target population

    Measured: 3 years after the beginning of the second step enrolment

Timeline

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

  1. First posted26 May 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionJun 2015 (estimated)
  4. Study completionJun 2015 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
485 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01361100
Sponsor's protocol ID
ONCORAL
Other IDs
ET 2010-015
Status last verified
Oct 2012
First submitted
8 Mar 2011
Last updated
2 Oct 2012
Results posted
No
Data monitoring committee
No

Publications

  • Castellsague X, Quintana MJ, Martinez MC, Nieto A, Sanchez MJ, Juan A, Monner A, Carrera M, Agudo A, Quer M, Munoz N, Herrero R, Franceschi S, Bosch FX. The role of type of tobacco and type of alcoholic beverage in oral carcinogenesis. Int J Cancer. 2004 Feb 20;108(5):741-9. doi: 10.1002/ijc.11627.

    PubMed 14696101

  • Lingen MW, Kalmar JR, Karrison T, Speight PM. Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncol. 2008 Jan;44(1):10-22. doi: 10.1016/j.oraloncology.2007.06.011. Epub 2007 Sep 6.

    PubMed 17825602

  • Nagler R, Bahar G, Shpitzer T, Feinmesser R. Concomitant analysis of salivary tumor markers--a new diagnostic tool for oral cancer. Clin Cancer Res. 2006 Jul 1;12(13):3979-84. doi: 10.1158/1078-0432.CCR-05-2412.

    PubMed 16818695

  • Tavassoli M, Brunel N, Maher R, Johnson NW, Soussi T. p53 antibodies in the saliva of patients with squamous cell carcinoma of the oral cavity. Int J Cancer. 1998 Oct 29;78(3):390-1. doi: 10.1002/(SICI)1097-0215(19981029)78:33.0.CO;2-9. No abstract available.

    PubMed 9766578

  • Peng G, Hakim M, Broza YY, Billan S, Abdah-Bortnyak R, Kuten A, Tisch U, Haick H. Detection of lung, breast, colorectal, and prostate cancers from exhaled breath using a single array of nanosensors. Br J Cancer. 2010 Aug 10;103(4):542-51. doi: 10.1038/sj.bjc.6605810. Epub 2010 Jul 20.

    PubMed 20648015

  • Mager DL, Haffajee AD, Devlin PM, Norris CM, Posner MR, Goodson JM. The salivary microbiota as a diagnostic indicator of oral cancer: a descriptive, non-randomized study of cancer-free and oral squamous cell carcinoma subjects. J Transl Med. 2005 Jul 7;3:27. doi: 10.1186/1479-5876-3-27.

    PubMed 15987522

  • Li Y, St John MA, Zhou X, Kim Y, Sinha U, Jordan RC, Eisele D, Abemayor E, Elashoff D, Park NH, Wong DT. Salivary transcriptome diagnostics for oral cancer detection. Clin Cancer Res. 2004 Dec 15;10(24):8442-50. doi: 10.1158/1078-0432.CCR-04-1167.

    PubMed 15623624

  • El-Naggar AK, Mao L, Staerkel G, Coombes MM, Tucker SL, Luna MA, Clayman GL, Lippman S, Goepfert H. Genetic heterogeneity in saliva from patients with oral squamous carcinomas: implications in molecular diagnosis and screening. J Mol Diagn. 2001 Nov;3(4):164-70. doi: 10.1016/S1525-1578(10)60668-X.

    PubMed 11687600

  • Liao PH, Chang YC, Huang MF, Tai KW, Chou MY. Mutation of p53 gene codon 63 in saliva as a molecular marker for oral squamous cell carcinomas. Oral Oncol. 2000 May;36(3):272-6. doi: 10.1016/s1368-8375(00)00005-1.

    PubMed 10793330

  • Anker P, Lyautey J, Lederrey C, Stroun M. Circulating nucleic acids in plasma or serum. Clin Chim Acta. 2001 Nov;313(1-2):143-6. doi: 10.1016/s0009-8981(01)00666-0.

    PubMed 11694252

  • Li Y, Zhou X, St John MA, Wong DT. RNA profiling of cell-free saliva using microarray technology. J Dent Res. 2004 Mar;83(3):199-203. doi: 10.1177/154405910408300303.

    PubMed 14981119

  • Rieger-Christ KM, Mourtzinos A, Lee PJ, Zagha RM, Cain J, Silverman M, Libertino JA, Summerhayes IC. Identification of fibroblast growth factor receptor 3 mutations in urine sediment DNA samples complements cytology in bladder tumor detection. Cancer. 2003 Aug 15;98(4):737-44. doi: 10.1002/cncr.11536.

    PubMed 12910517

  • Phillips M, Gleeson K, Hughes JM, Greenberg J, Cataneo RN, Baker L, McVay WP. Volatile organic compounds in breath as markers of lung cancer: a cross-sectional study. Lancet. 1999 Jun 5;353(9168):1930-3. doi: 10.1016/S0140-6736(98)07552-7.

    PubMed 10371572

  • Miekisch W, Schubert JK, Noeldge-Schomburg GF. Diagnostic potential of breath analysis--focus on volatile organic compounds. Clin Chim Acta. 2004 Sep;347(1-2):25-39. doi: 10.1016/j.cccn.2004.04.023.

    PubMed 15313139

Questions about this trial

What is this clinical trial studying?

A study testing Oncoral® test in people with Carcinoma, run by Centre Leon Berard at 8 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 13 inclusion and 13 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 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sophie DUSSART, MD (+33 478 78 27 52, sophie.dussart@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First step: Confirm that the parameters used for the development of the test to qualify it as positive or negative lead to the same level of sensitivity (98%) (time frame: 1 year after the beginning of enrollment). The study lists 2 primary outcomes in all. 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 NCT01361100, which also lists 14 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 2 Oct 2012.

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