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De status van het micromilieu van de (schildwacht)klier en tumor bij patiŽnten met baarmoederhalskanker.


- candidate number28370
- NTR NumberNTR7020
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-dec-2017
- Secondary IDsM17GINC NL62567.031.17
- Public TitleDe status van het micromilieu van de (schildwacht)klier en tumor bij patiŽnten met baarmoederhalskanker.
- Scientific TitleThe state of the (sentinel) lymph node and tumour microenvironment in patients with cancer of the cervix.
- ACRONYMGINA (cervix)
- hypothesisThis is an exploratory study to further delineate the microenvironment of the PT and (S)LNs in cervical cancer.
- Healt Condition(s) or Problem(s) studiedCervix cancer, Human Papilloma Virus (HPV), Sentinel lymph node, Lymph nodes
- Inclusion criteria- Age ≥ 18 years at start of the study;
- Primary carcinoma of the cervix;
- Operation at the NKI-AVL or AMC/VUmc;
- Signed informed consent.
- Exclusion criteria- Patients with cervical cancer other than squamous, adeno- or adenosquamous origin.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-feb-2018
- planned closingdate1-feb-2023
- Target number of participants100
- Interventions- patients will be asked to give permission to search for sentinel node(s), by injecting patent blue
- patients will be asked to donate 2x 10 ml blood for further analysis (at two different timepoints)
- Primary outcomeTo analyse the microenvironment of (S)LNs and PT (i.e. antigen presenting cells and other immune cells) and other immune
factors produced by the tumour cells in patients with cervical cancer.
- Secondary outcome- to assess the difference of the microenvironment of tumour-negative and metastatic LNs
- to assess the difference of the microenvironment of SLNs and nonSLNs
- to analyse the difference in the (S)LNs compared to the primary tumour
- to assess the effect of the cervical tumour on the systemic immunity
- Timepoints- blood will be drawn before surgery and 3 months after surgery
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESdrs. Jossie Rotman
- CONTACT for SCIENTIFIC QUERIESdrs. Jossie Rotman
- Sponsor/Initiator NKI-AVL
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publications
- Brief summaryThis is an exploratory study to further delineate the microenvironment of the primary tumour and (sentinel) lymph nodes in cervical cancer.All patients diagnosed with cervical carcinoma who will undergo an operation or a lymphadenectomy will be asked to participate in the study. Patients who will undergo a lymphadenectomy will be asked to participate in detecting the SLNs prior to the lymph node dissection by injecting ICG/patent blue in the tumour before the operation starts in the operation room. Patients who will undergo a lymph node debulking in the context of chemoradiotherapy, will be asked permission to obtain a small tumour biopsy.
- Main changes (audit trail)METC approval since 16-feb-2018.
- RECORD21-dec-2017 - 23-feb-2018


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