ETUDE DES 3 CITÉS THREECITY (3C) STUDY ANCILLARY STUDY

PROTOCOLE D’ETUDE OBSERVATIONNELLE AVEC RECUEIL DE DONNEES INDIRECTEMENT
128 VAN ACHTER S ETUDE DE LA FIABILITÉ
2167 FR DEF BOIS & ECOLOGIE ETUDE DE L’INSTITUT

7 1 – PRESENTATION DE L’ETUDE 11 CADRE
ANALYSE DE LA COMPLETUDE DU DOSSIER 1 FORMULAIRE DE
ARTICLE PARU DANS LA LANGUE LIBÉRÉE ETUDES DE SOCIOLEXICOLOGIE

DRAFT

ETUDE DES 3 CITÉS THREECITY (3C) STUDY ANCILLARY STUDY



Etude des 3 Cités /Three-City (3C) Study


Ancillary Study Proposal Form



Preliminary Information:

Investigators unaffiliated with any of the 3C-Study founding teams are welcome to propose new studies or new analyses (termed ancillary studies). Non-3C Study investigators are encouraged to work in collaboration with a senior investigator from one of the 3C-Study founding teams (listed in: Investigators, Study Sites, Collaborating Centres and Working Groups). The 3C-Study correspondent investigator can either be contacted directly by an investigator submitting an ancillary study, or can be designated by the 3C-Study Steering Committee.


Ancillary study proposals must be sent to the Coordinating Centre ([email protected]), for review by the Steering Committee. Six to eight weeks should be allowed for completion of the approval process. Ancillary studies that require transmission of biological materials, particularly outside of France, or that involve for-profit organizations, may require extra time for approval. Extra time should also be allowed when the outcome of the proposed study may possibly lead to a patent.


The present application form, as well as the Data Transmission Agreement (available on the 3C-Study website) must be completed and submitted to the Steering Committee for final approval.


Costs for the ancillary study must be reviewed with the Steering Committee before final approval. Such costs are those that involve transmission of data, and, when applicable, transmission of biological samples.


When a for-profit organization is directly or indirectly involved in the proposed ancillary study, a specific contract agreement detailing the financial arrangements may be drawn up.


If new data – clinical, as well as biological in nature– are collected as part of the ancillary study, these data will eventually be merged into the main database. The ancillary study principal investigator is initially given the primary and exclusive right to analyse and publish the data for a one-year period following submission of the data to the Coordinating Centre. After this period, these data become accessible to other investigators.


Finally, if the new data to be collected require a face-to-face contact (interview or investigation) with the 3C-study participants, this data collection should be part of planned follow-up examinations.



A: Information regarding the proposed Ancillary Study


  1. Title of study


  1. Principal investigator of the ancillary study (name, institution, address, telephone and fax numbers, e-mail address)


  1. List of all investigators expected to participate in the ancillary study




B: Description of the proposed Ancillary Study (2 to 4 pages)


Background and rationale

Methods implemented, including new data to be collected (if any), 3C Study data required (specify which baseline data, follow-up data, and events) and analysis plan

Sample size justification

Main literature references



C: Additional information



1. Requirements of the proposed study (check one or more)

• Existing 3C-Study data only, possibly including existing biological and genetic data ____ (Complete points 6 and, if applicable, 7)

• Existing 3C-Study data plus new biological measurements (or genetic investigations) on stored biological specimens ____ (Complete points 5 and 6)

• Existing 3C-Study data plus collection of new data in 3C participants ____ (Complete point 4)


  1. Does this study involve the support or collaboration of a for-profit entity


Yes _____ No ____


If yes, provide the names and details of this or these for-profit entities.



  1. If the proposed ancillary study requires collection of new data from participants, describe a) the size and the characteristics of the participant sample (whole cohort or specific subgroups), b) the mode of participant involvement (questionnaires, investigations, etc.), and c) duration of the interview/examination, and of the participation of 3C-Study staff at each Field Centre.






  1. Indicate if the proposed study will use:


Stored biological specimens ____

DNA ____

Both of these materials ____


a. For a study using stored biological specimens, describe: the sample type (serum, EDTA, etc.), sample volumes needed, and provide the name and address of the laboratory that will analyse the specimens.


b. For a study using DNA:

Will the study use genetic information obtained from the genome-wide study carried out with 3C Study participants? Yes ____ No ____


Will the study use specific SNPs that have already been genotyped (refer to the list on the 3C-Study website)? Yes ____ No ____


Will the study use DNA material for genetic investigations not yet carried out in the 3C Study ? Yes ____ No ____


If yes, provide details of these investigations.


  1. Data (other than genetic data)


Describe the size and the characteristics (whole cohort, specific subgroups, etc.) of the participant sample, and summarize the 3C-Study data to be analysed (the detailed list must be included in the ‘Data Transmission Agreement’).


  1. Genetic information


Will 3C-Study participants be used as a control population in a genetic association study? Yes ____ No ____


If yes, describe the case population: phenotype, size, recruitment.


If no, describe the phenotype/health condition of the 3C-participants under study, the genes to be investigated, and the SNPs to be genotyped.

  1. Patent

Could the propose study result in a patent? Yes ____ No ____

  1. Check the following statements:


The principal investigator of the ancillary study will report progress of the study to the 3C-Study coordinating investigator, as required in the data transmission agreement. ______


The data listed in the Data Transmission Agreement will be transmitted to the principal Investigator of the ancillary study once the Coordinating Centre has received the data collected from the ancillary study (biologic measurements, genetic testing and other new data), when applicable. These data will be integrated into the main database. (See ‘Preliminary Information’, above).

Not applicable (no new data collection or biological/genetic measurements) ____

Applicable ____

Before submitting the results of an ancillary study for publication at a congress, seminar, meeting, or for review, the principal investigator must send the manuscript to the Coordinating Centre (refer to the Manuscript Application Form on the 3C Study website) for review by the Steering Committee. In all cases, the policy regarding proposals of 3C-Study papers will be applied. ____



Publications should describe the 3C-Study in ‘Material and Methods’. At a minimum, the following sentence should be included: “The 3C-Study was designed to examine the relationship between vascular diseases and dementia in a community housing 9,294 persons aged 65 years and over”. ____


If, for any reason, the results of the ancillary study are not published, the principal investigator must, in any case send a report of the results to the Coordinating Centre. ____





Please e-mail the completed application form to Christophe Tzourio at

[email protected]





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