Metformin clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT04947020 Active, not recruiting - Rectal Cancer Clinical Trials

dataBase for Analysis of Rectal Cancer Oncological Results

BARO

Start date: August 1, 2021
Phase:
Study type: Observational

The data will be obtained from 10 tertiary centers located in Poland (Cracow - coordinating center, Warsaw - 3 centers, Sosnowiec, Szczecin, Bydgoszcz, Lublin, Gdansk, Poznan) and 5 foreign centers. The analyses will include patients with rectal cancer operated on between 2013-2019. A database in MS Excel is prepared that consists of following data: - Type of neoadjuvant treatment (if any) - Time-interval between the end of neoadjuvant treatment and surgery - Type of surgery - Staging of rectal cancer i.e. (y)pTNM - Number of retrieved lymph nodes - Number of lymph nodes with metastases - R classification (R0, R1, R2) - Preoperative medications (metformin, statins, NSAIDs, anticoagulants) - Recurrence date and type (local, systemic, both diagnosed at the same time) - Date of death or date of last follow-up visit The aims of the study are following: 1. Establishing whether neoadjuvant treatment (PSCR or chemoradiotherapy) influences number of retrieved lymph nodes in rectal cancer 2. Establishing whether time-interval between the end of PSCR and surgery influences lymph node yield 3. Establishing the prognostic value of lymph node ratio - validation of the previously calculated cutoff point at the level of 0.41 4. Determining independent prognostic factors in rectal cancer - in particular related to medications taken before the operation, metformin and anti diabetic drugs in the first place