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Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa (RFAOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803735
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
French Africa Pediatric Oncology Group

Brief Summary:

The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group. This data will help to plan and provide correct pediatric oncology treatment and care for this population.

Collecting the data will give much needed information on numbers, stage, treatment and outcome. The register will give data for local and national health authorities in planning pediatric cancer programs.


Condition or disease
Pediatric Cancer

Detailed Description:

This register is a registration of all children entering hospital based pediatric oncology units, working in selected hospitals in French speaking Africa. The data collected includes: demographic and socioeconomic status as well as clinical status and outcome.

The register also collects information on vital status, treatment abandonment and loss to follow-up.

Data, collected locally is entered on line using the Research Electronic Data Capture (REDCap) program. Data are stored under the responsibility of the IT department at Gustave ROUSSY in Paris- Villejuif.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: French African Pediatric Oncology Registry
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025



Primary Outcome Measures :
  1. Number of children with a suspicion of any type of cancer in a given unit [ Time Frame: in any 12 month period ]

    Number of children with details of :

    1. the type of cancer
    2. the stage of the identified cancer coming into a given unit

  2. VITAL STATUS: [ Time Frame: in any 12 month period ]

    Dead or alive

    1. The number of children living
    2. the number of children dead

  3. Illness status [ Time Frame: in any 12 month period ]
    1. The number of children relapsed,
    2. The number of children whos illness has progressed.

  4. Treatment Status [ Time Frame: in any 12 month period ]
    1. The number of children who had treatment administered,
    2. The number of children who abandoned treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All childre with any pediatric cancer types, coming into any one of the participating units in a 12 month period.
Criteria

Inclusion Criteria:

  1. Any child presenting at any one of the participating units for treatment
  2. Any child with any type of cancer
  3. Any child or adolescent less than 18 years of age.

Exclusion Criteria:

  1. No cancer found
  2. Age greater than 18 years -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803735


Contacts
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Contact: Brenda MALLON, MSC + 33142115411 brenda.mallon@gustaveroussy.fr
Contact: Catherine PATTE, DR + 33142116560 catherine.patte@gustaveroussy.fr

Locations
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France
GFAOP Recruiting
Villejuif, Paris, France, 00094
Contact: BRENDA MALLON, MSC    0033661519474    brenda.mallon@gustaveroussy.fr   
Contact: CATHERINE PATTE, DR    0033142116560    catherine.patte@gustaveroussy.fr   
Sponsors and Collaborators
French Africa Pediatric Oncology Group
Gustave Roussy, Cancer Campus, Grand Paris
Additional Information:

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Responsible Party: French Africa Pediatric Oncology Group
ClinicalTrials.gov Identifier: NCT03803735    
Other Study ID Numbers: GFAOP
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Units have acess to their own data and can use it for reporting.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No