FMT plus ICI therapy in metastatic renal cell carcinoma, Italy
255 stool samples from adult metastatic renal cell carcinoma patients and donors in Italy, from the TACITO randomized placebo-controlled phase 2a trial testing donor fecal microbiota transplantation combined with pembrolizumab and axitinib. machine-written summary
255 samples · 255 runs · IT · Adult · 2025 · 11.92 Gbp / sample
Checked this project's papers and archive records yourself? Mark it human-verified.
what each source gave
| ✓ Sequence archive | 1,512 sample values (collection date, country, health condition, health condition detail, subject id, timepoint) |
| ○ Abstract / description | read; no usable statement |
| ✓ Full text | 255 sample values (location site) · PMC13099650 |
| ○ Supplementary tables | files read; no table could be matched to the samples |
| – External resources | not covered by the external resources we ingest |
| – User contribution | nothing uploaded yet |
| – Human verified | not yet checked by a person · I checked this project — verify it |
intervention — arms not resolved
Non-antibiotic pharmaceutical given as the study intervention (metformin Faecal microbiota transplantation design randomized_controlled_trial · population other_cancer · Donor FMT vs placebo FMT plus pembrolizumab and axitinib
“randomized, double-blind placebo-controlled phase 2a TACITO trial” — abstract:41606119 (study level; per-sample arms are in the intervention column below)
longitudinal — not resolvedFMT donor → recipient — not resolved
44 of 46 people sampled more than once (244 samples; median 6, up to 7 per person). Schedule stated by the source: “Patients sampled at baseline and 1,4,12,24,36,52 weeks after first FMT treatment; donors sampled per donated aliquot.” (time origin: intervention_start); stated follow-up 2.7 y.
TACITO FMT trial: donor aliquot samples (DTT001 x8, DTT005 x1) and patient stool; per-patient donor link not given per sample.
Genera, mean relative abundance over 249 profiled gut samples of this project (Sandpiper SingleM profiles, GTDB R232; low-depth and non-metagenome profiles left out).
| field | samples | coverage | R1 | R2 | R3 | R4 |
|---|---|---|---|---|---|---|
| age_category | 255 | 100% | ||||
| country | 255 | 100% | 255 | |||
| health_condition | 255 | 100% | 255 | |||
| subject_id | 246 | 96% | 246 | |||
| collection_date | 255 | 100% | 255 | |||
| detailed_location | 255 | 100% | ||||
| health_condition_detail | 255 | 100% | 255 | |||
| location_site | 255 | 100% | 255 | |||
| timepoint_label | 246 | 96% | 246 |
- Fecal microbiota transplantation plus pembrolizumab and axitinib in metastatic renal cell carcinoma: the randomized phase 2 TACITO trial. 2026 PMID 41606119 PMC13099650 own_data
Archive description
Clinical trial (TACITO) for the evaluation of the efficacy of targeted fecal microbiota transplantation (FMT) in improving response rates to immune checkpoint inhibitors (ICIs) in subjects with treatment-naïve metastatic renal cell carcinoma. In this investigator-initiated phase 2a placebo-controlled randomized clinical trial, FMT from donors who are responding to ICIs (or a placebo FMT, in the control arm) was combined with first-line therapy with pembrolizumab and axitinib. Patients underwent the first FMT infusion by colonoscopy. Then, patients received frozen fecal capsules (8 capsules t.i.d.) at 3 and 6 months after the first FMT. Stool samples from donors were collected from all donated aliquots, and from patients at baseline, one, four, 12, 24, 36, and 52 weeks after the first treatment, which was followed by shotgun metagenomic sequencing and microbiome characterization for donor strain engraftment estimation.
How this project entered the registry
Classified as human gut / stool shotgun DNA metagenome of adult by deterministic_prior with confidence 0.90. Assay shotgun_dna.
- host external_curation.infant_catalog · “infant triage reason_code age_adult_only”
- body site study.title · “of targeted of fecal microbiota transplantation (FMT)”
- body site study.description · “efficacy of targeted fecal microbiota transplantation (FMT)”
- life stage external_curation.infant_catalog · “infant triage reason_code age_adult_only”
Evidence examples (one per field × route)
| sample | field | value | route | conf. | source | quote |
|---|---|---|---|---|---|---|
| SAMEA120155657 | collection_date | 2021 | R1 | 0.90 | biosample.attribute:collection_date | 2021 |
| SAMEA120155657 | country | IT | R1 | 0.90 | sample.attr.geographic_location_country_and_or_sea | Italy |
| SAMEA120155657 | health_condition | other_cancer | R1 | 0.85 | biosample.attribute:description | Stool sample from the TACITO trial |
| SAMEA120155657 | health_condition_detail | Stool sample from the TACITO trial | R1 | 0.85 | biosample.attribute:description | Stool sample from the TACITO trial |
| SAMEA120155657 | location_site | Fondazione Policlinico Gemelli IRCCS | R3 | 0.70 | paper.fulltext.methods | enrolled in the Fondazione Policlinico Gemelli IRCCS |
| SAMEA120155666 | subject_id | 001 | R1 | 0.70 | sample.name_rule:alias | FMT_T001_t360 |
| SAMEA120155666 | timepoint_label | 360 | R1 | 0.70 | sample.name_rule:alias | FMT_T001_t360 |
Sequencing
255 runs over 255 samples · mean 12.98 Gbp per run (median 11.92 Gbp, total 3,311.15 Gbp; 255 runs with a base count) · layout PAIRED 255 · platform ILLUMINA 255 · models unspecified (255) · 98% of runs with a Sandpiper profile · first public 2025-10-18
Authors (33)
Porcari S first · Ciccarese C · Heidrich V · Rondinella D · Quaranta G · Severino A · Arduini D · Buti S · Fornarini G · Primi F · Stumbo L · Giannarelli D · Giudice GC · Damassi A · Giron Berríos JR · Punčochář M · Barbazuk TB · Piccinno G · Pinto F · Armanini F · Asnicar F · Schinzari G · Derosa L · Kroemer G · Sanguinetti M · Masucci L · Gasbarrini A · Tortora G · Cammarota G · Zitvogel L · Segata N · Iacovelli R · Ianiro G last
Downloads
PRJEB94043.csv.gz (7.1 KB) · parquet (78.6 KB) — all 255 samples, every field with route and confidence · PRJEB94043_determinations.csv.gz (11.6 KB) — 1,767 evidence rows